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Product Classification / EMDN Category

FDA Product Code: OLO

Directory of devices assigned to product classification code OLO.

classification Orthopedic Stereotaxic Instrument Manufacturer:
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gudid NextAR Spine Universal Camera Adapter Kit Manufacturer: Medacta International SA
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gudid NextAR Spine Tray MC Instruments Manufacturer: Medacta International SA
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gudid NextAR Knee software Manufacturer: Medacta International SA
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gudid Threaded Pin 3.2 x 4.2 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Pin With Stop 3.2 Lungh.40 Manufacturer: ORTHOKEY ITALIA SRL
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gudid Pin 3.2 x 120 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Pin 3.2 x 80 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Femural Spacer 10 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Alignment Verification ROD Manufacturer: ORTHOKEY ITALIA SRL
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gudid Box Sterilizzation Manufacturer: ORTHOKEY ITALIA SRL
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gudid Non Invasive Sensor Support (includes Silicon Strip, code 1165) Manufacturer: ORTHOKEY ITALIA SRL
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gudid Jacobs Adaptor Manufacturer: ORTHOKEY ITALIA SRL
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gudid Pin Extractor Manufacturer: ORTHOKEY ITALIA SRL
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gudid Femoral Spacer 9 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Perseus Tibial Cutting Guide R - 1.3 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Perseus Tibial Cutting Guide L - 1.3 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Femur Cutting Guide 1.3 mm Manufacturer: ORTHOKEY ITALIA SRL
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gudid Extramedullary Jig Manufacturer: ORTHOKEY ITALIA SRL
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gudid Perseus Device Sensor Manufacturer: ORTHOKEY ITALIA SRL
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gudid The Dynamis Robotic Surgical System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include cervical, thoracic, lumbar, and sacral approaches. The system is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table. The cart employs bilateral elevator mechanisms to deploy and fold the surgical robotic arms and secure them. This system functions in conjunction with different intraoperative imaging systems by data transfer of DICOM format images by USB and/or Direct LAN transfer for intraoperative planning. The system software is responsible for all motion control, navigation, data storage, user management, case management, and safety functions. The system establishes registration between the virtual patient (points on the patient DICOM images) and the physical patient (corresponding to the patients anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during the robotic alignment of qualified instruments or during free-hand navigation. Qualified instruments that are rigid, straight, round, and concentric are permitted for use through the Dynacan or used with the Dynatracker, given they pass the Instrument Setup process.The system also supports individual vertebra tracking to maintain alignment to vertebra specific trajectories by monitoring relative vertebral motion, as well as a stabilization workflow which provides additional control of vertebral motion during instrumentation. Manufacturer: LEM Surgical AG
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gudid The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System. Manufacturer: LEM Surgical AG
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gudid Neo ADVISE Manufacturer: Comerge AG
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gudid PERLA TL NAV. CORTICAL SCREWDRIVER TUBE Manufacturer: SpineArt SA
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gudid PERLA TL NAV LOCKING SCREWDRIVER XTAB Manufacturer: SpineArt SA
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gudid PERLA TL NAV. SCREWDRIVER XTAB Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 10.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 10.0 (10.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 9.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 9.0 (9.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 8.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 8.0 (8.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 7.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 7.0 (7.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 6.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 6.0 (6.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 5.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CANNULATED TAP 5.0 (5.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. ADJUSTABLE DRILL GUIDE Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL SCREWDRIVER SHAFT Manufacturer: SpineArt SA
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gudid PERLA TL NAV. DRILL 3.1 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 7.5 (7.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 7.0 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 6.5 (6.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 6.0 (6.0 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 5.5 (5.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 5.0 (5.0 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. CORTICAL TAP 4.5 (4.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. LOCKING SCREWDRIVER SS Manufacturer: SpineArt SA
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gudid PERLA TL NAV. LOCKING SCREWDRIVER MS-PS CANNULATED Manufacturer: SpineArt SA
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gudid PERLA TL NAV. SCREWDRIVER UNIVERSAL CANNULATED Manufacturer: SpineArt SA
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gudid PERLA TL NAV. SCREWDRIVER SS Manufacturer: SpineArt SA
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gudid PERLA TL NAV. SCREWDRIVER MS-PS CANNULATED Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 10.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 10.0 (10.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 9.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 9.0 (9.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 8.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 8.0 (8.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 7.5 Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 7.0 (7.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 6.5 (7.0 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 6.0 (6.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 5.5 (6.0 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 5.0 (5.5 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 4.5 (5.0 SCREW) Manufacturer: SpineArt SA
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gudid PERLA TL NAV. TAP 4.0 (4.5 SCREW) Manufacturer: SpineArt SA
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gudid BRAINLAB NAVIGATION ADAPTOR Manufacturer: SpineArt SA
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gudid ECENTIAL NAVIGATION ADAPTOR Manufacturer: SpineArt SA
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gudid LOCKING SCREWDRIVER CANNULATED Manufacturer: SpineArt SA
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gudid LOCKING SCREWDRIVER Manufacturer: SpineArt SA
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gudid DRILL GUIDE Manufacturer: SpineArt SA
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gudid DRILL GUIDE ADJUSTABLE SLEEVE Manufacturer: SpineArt SA
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gudid DRILL 3.1 Manufacturer: SpineArt SA
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gudid DRILL 2.4 Manufacturer: SpineArt SA
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gudid Apollo Robot Extended Enclosure Body Manufacturer: CORIN LTD
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gudid ApolloKnee Tracker and Pin Kit Manufacturer: CORIN LTD
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gudid Sawing guide with calibration track - Extended Manufacturer: CORIN LTD
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gudid Apollo BalanceBot Cable Manufacturer: CORIN LTD
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gudid Apollo Robot Cable Manufacturer: CORIN LTD
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gudid Cancellous bone screw 5.5mm x 93mm Manufacturer: CORIN LTD
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gudid Cancellous bone screw 5.5mm x 73mm Manufacturer: CORIN LTD
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gudid Cortical bone Screw 3.2mm x 110mm Manufacturer: CORIN LTD
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gudid Cortical bone Screw 3.2mm x 80mm Manufacturer: CORIN LTD
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gudid Cortical bone screw 4mm x 150mm Manufacturer: CORIN LTD
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gudid Cortical bone Screw 4mm x 120mm Manufacturer: CORIN LTD
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gudid Extended Femur Bone Fixation Manufacturer: CORIN LTD
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gudid Station Power Cable Manufacturer: CORIN LTD
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gudid Camera Assembly ST Manufacturer: CORIN LTD
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gudid Camera Assembly VT Manufacturer: CORIN LTD
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gudid Apollo Station (EU) Manufacturer: CORIN LTD
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gudid ApolloKnee Software Manufacturer: CORIN LTD
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gudid Tibial Cutting Guide Rail Manufacturer: CORIN LTD
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gudid Apollo Station (US) Manufacturer: CORIN LTD
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gudid BalanceBot Manufacturer: CORIN LTD
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gudid Pre-Resection Tibial Fixation Block Manufacturer: CORIN LTD
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gudid Pre-Resection BalanceBot Paddles, Right B Manufacturer: CORIN LTD
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gudid Pre-Resection BalanceBot Paddles, Left B Manufacturer: CORIN LTD
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gudid Pre-Resection BalanceBot Paddles, Right A Manufacturer: CORIN LTD
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gudid Pre-Resection BalanceBot Paddles, Left A Manufacturer: CORIN LTD
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