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Cobalt Mv Bone Cement

by Biomet Manufacturing Corp

510(k) K091608

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 · Traditional NumberK091608 Date17 Sep 2009ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0065-2018 FDA Class II initiated 26 Jun 2017
    • Ongoing Z-0066-2018 FDA Class II initiated 26 Jun 2017

    Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

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  • Withdrawn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
LOD
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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