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Synthes 3.5MM Lcp Clavicle Plate System

by Synthes (Usa) 2 variants

510(k) K073186

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073186 Date17 Dec 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.