Synthes 3.5MM Lcp Clavicle Plate System
510(k) K073186
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073186 | Date17 Dec 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Synthes 3.5mm Lcp Clavicle Plate System is a device used for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. It is an orthopedic device, specifically designed for clavicle fixation. The device is part of the Lcp system, which features locking screw technology. It is used in orthopedic procedures to stabilize and align the clavicle. The device is designed to provide stable fixation of the clavicle, allowing for proper healing and recovery.
The Synthes 3.5mm Lcp Clavicle Plate System is supplied as a single unit, with a specific product code of HRS and k number of K073186. It is authorized with an FDA 510K clearance. The device is intended for use in adults and in cases where the clavicular growth plates have fused. The system is designed for fixation of various clavicle conditions, including fractures, osteotomies, and nonunions.
Other devices from Synthes (Usa)
Questions
AI-generated answers, 24 Sep 2026
What is the Synthes 3.5mm LCP Clavicle Plate System used for?
The Synthes 3.5mm LCP Clavicle Plate System is used for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle, providing stable fixation for proper healing and recovery.
Is the Synthes 3.5mm LCP Clavicle Plate System supplied sterile?
The description does not specify if the device is supplied sterile, but it is intended for use in orthopedic procedures, suggesting that sterilization may be required before use.
What is the product code for the Synthes 3.5mm LCP Clavicle Plate System?
The product code for the Synthes 3.5mm LCP Clavicle Plate System is HRS, with a k number of K073186.
Is the Synthes 3.5mm LCP Clavicle Plate System intended for use in adults or children?
The device is intended for use in adults and in cases where the clavicular growth plates have fused, suggesting that it may not be suitable for use in children with open growth plates.