Clavicle Locking Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100944 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a clavicle locking plate system used for the fixation of clavicle fractures, delayed unions, non-unions, and osteotomies in adults. It is designed for middle-third clavicle fracture treatment and includes plates and instruments for osteosynthesis.
The system is supplied as part of sterile single-use kits, including middle-third plate kits in sizes 1 and 2, asymmetrical for right and left sides. It features oblong holes for Ø3.5 mm non-locking screws and holes for Ø3.5 mm locking and non-locking screws. The device received FDA 510(k) clearance (K100944) and is classified under product code HRS.
Frequently asked questions
What is the Clavicle Locking Plate System used for?
The Clavicle Locking Plate System is used for the fixation of clavicle fractures, delayed unions, non-unions, and osteotomies in adults, specifically designed for middle-third clavicle fracture treatment as part of osteosynthesis procedures.
How is the Clavicle Locking Plate System supplied and is it sterile or reusable?
The system is supplied as sterile single-use kits, including middle-third plate kits in sizes 1 and 2, asymmetrical for right and left sides, ensuring each kit is intended for one-time use only to maintain sterility and prevent cross-contamination.
What screw sizes and hole types are featured in the Clavicle Locking Plate System?
The system features oblong holes for Ø3.5 mm non-locking screws and dedicated holes for both Ø3.5 mm locking and non-locking screws, allowing flexibility in fixation techniques during clavicle osteosynthesis.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alians Clavicle S. - Clavicle traumatology - Newclip Technics, INITIAL C - Clavicle - Newclip Technics, Clavicle. - Kit d'instruments à usage unique - Newclip Technics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100944 | Class II | Active |
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Manufacturer
- Manufacturer
- Newclip Technics
Sources (1)
- FDA 510(k) K100944 24 fields · synced Oct 1, 2026