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Tornier, Inc Registered Devices

Listing registered devices, PMA filings, and compliance records for Tornier, Inc.

enforcement Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 ID: Z-1769-2026
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enforcement TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 ID: Z-1237-2026
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enforcement stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented ID: Z-1651-2025
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enforcement Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty ID: Z-3309-2024
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enforcement stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder ID: Z-3155-2024
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enforcement Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. ID: Z-1374-2018
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enforcement Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. ID: Z-2025-2021
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enforcement AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly. ID: Z-2199-2013
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enforcement Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument ID: Z-2465-2015
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enforcement Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. ID: Z-2315-2015
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enforcement Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation. ID: Z-0699-2017
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enforcement AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures). ID: Z-1757-2018
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enforcement Aequalis Ascend Flex Humeral Stem: Part NumberUDI DWF601A3700386944475 DWF601B3700386944482 DWF601C3700386944499 DWF602A3700386944505 DWF602B3700386944512 DWF602C3700386944529 DWF603A3700386944536 DWF603B3700386944543 DWF603C3700386944550 DWF604A3700386944567 DWF604B3700386944574 DWF605A3700386944598 DWF605B3700386944604 DWF605C3700386944611 DWF606A3700386944628 DWF606B3700386944635 DWF606C3700386944642 DWF607A3700386944659 DWF607B3700386944666 DWF607C3700386944673 DWF608A3700386944680 DWF608B3700386944697 DWF608C3700386944703 DWF609A3700386944710 DWF609B3700386944727 DWF609C3700386944734 DWF611A3700386944741 DWF611B3700386944758 DWF611C3700386944765 DWF612A3700386944772 DWF612B3700386944789 DWF612C3700386944796 DWF613A3700386944802 DWF613B3700386944819 DWF613C3700386944826 DWF614A3700386944833 DWF614B3700386944840 DWF614C3700386944857 DWF615A3700386944864 DWF615B3700386944871 DWF615C3700386944888 DWF616A3700386944895 DWF616B3700386944901 DWF616C3700386944918 DWF617A3700386944925 DWF617B3700386944932 DWF617C3700386944949 DWF618A3700386944956 DWF618B3700386944963 DWF618C3700386944970 DWF619A3700386944987 DWF619B3700386944994 DWF619C3700386945007 DWF702A3700386945045 DWF702B3700386945052 DWF702C3700386945069 DWF703A3700386945076 DWF703B3700386945083 DWF703C3700386945090 DWF704A3700386945106 DWF704B3700386945113 DWF704C3700386945120 DWF705A3700386945137 DWF705B3700386945144 DWF705C3700386945151 DWF706A3700386945168 DWF706B3700386945175 DWF706C3700386945182 DWF707A3700386945199 DWF707B3700386945205 DWF707C3700386945212 DWF708A3700386945229 DWF708B3700386945236 DWF708C3700386945243 DWF709A3700386945250 DWF709B3700386945267 DWF709C3700386945274 DWF712A3700386945311 DWF712B3700386945328 DWF712C3700386945335 DWF713A3700386945342 DWF713B3700386945359 DWF713C3700386945366 DWF714A3700386945373 DWF714B3700386945380 DWF714C3700386945397 DWF715A3700386945403 DWF715B3700386945410 DWF715C3700386945427 DWF716A3700386945434 DWF716B3700386945441 DWF716C3700386945458 DWF717A3700386945465 DWF717B3700386945472 DWF717C3700386945489 DWF718A3700386945496 DWF718B3700386945502 DWF718C3700386945519 DWF719A3700386945526 DWF719B3700386945533 DWF719C3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. ID: Z-0405-2020
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enforcement stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 ID: Z-0113-2024
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enforcement AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 ID: Z-2019-2023
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enforcement Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit ID: Z-1216-2022
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enforcement AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 ID: Z-2020-2023
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enforcement Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. ID: Z-0773-2024
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