Synthes Trauma Nail System. The devices are indication for bone fixation. (UDI Z-2058-2013)
Manufactured by Synthes USA HQ, Inc.
Device Regulatory Overview
The Synthes Trauma Nail System. The devices are indication for bone fixation. (Model/Catalog Number: Unspecified) is a medical device manufactured by Synthes USA HQ, Inc.. This product is indexed under FDA Product Code / Category Classification Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
- Device Name
- Synthes Trauma Nail System. The devices are indication for bone fixation.
- Database Sync Date
- 2026-08-09 10:06:38
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Synthes Trauma Nail System. The devices are indication for bone fixation.?
The registered manufacturer of record for Synthes Trauma Nail System. The devices are indication for bone fixation. is Synthes USA HQ, Inc..
What is the Primary UDI-DI identifier for Synthes Trauma Nail System. The devices are indication for bone fixation.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2058-2013.
What classification code is assigned to this device?
This device is registered under product classification code Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897.
Other Devices by Synthes USA HQ, Inc.
- → Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
- → Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
- → Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- → 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
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