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Osteomed Low Profile Neuro Fixation System

by Osteomed LP

510(k) K111176

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Special NumberK111176 Date15 Aug 2011ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2107-2023 FDA Class II initiated 31 May 2023
    • Ongoing Z-2108-2023 FDA Class II initiated 31 May 2023

    Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

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  • Withdrawn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
GWO
Device Class
Class II
Regulation
21 CFR Part 882.5320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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