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Biomet Microfixation Neuro Plating System

by Biomet Microfixation

510(k) K121624

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK121624 Date12 Oct 2012ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0137-2016 FDA Class II initiated 6 Aug 2015
    • Terminated Z-0136-2016 FDA Class II initiated 6 Aug 2015

    The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

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  • Withdrawn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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