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Synthes Anatomical Locking Plate System

by Synthes (Usa)

510(k) K961413

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 NumberK961413 Date7 Aug 1996ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
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 Anatomical Locking Plate System is an orthopedic device designed for fixation of bone fractures. It is a locking plate system intended to provide stable internal fixation in anatomical locations where traditional plating may be challenging.

The system is supplied as a reusable surgical instrument set and is used in orthopedic trauma surgery. It is compatible with 3.5 mm locking, cortex, locking cannulated, and 4.0 mm cancellous screws. The device received FDA 510(k) clearance (K961413) as substantially equivalent to a predicate device and is classified under product code HWC with orthopedic advisory committee review.

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