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Synthes (USA) Oribital Mesh Plates

by Synthes (Usa)

510(k) K001311

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 NumberK001311 Date20 Jun 2000ClearedStatusActive

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  • Withdrawn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, 19 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 Orbital Mesh Plates are orthopedic fixation devices designed for internal stabilization of orbital fractures. Constructed from alloys such as cobalt-chromium-molybdenum, stainless steel, or titanium, these plates are secured in place using fasteners like screws, nails, or combinations of bolts, nuts, and washers to restore anatomical alignment and structural integrity.

These plates are intended for surgical use in an operating room setting and are supplied sterile for single-use. They are classified under product code HRS and were cleared through the Traditional 510(k) pathway by the FDA in 2000 under the Orthopedic advisory committee. No additional regulatory status beyond the stated FDA clearance is implied.

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