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Comprehensive Convertible Glenoid

by Biomet Manufacturing, Inc.

510(k) K130390

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK130390 Date9 Oct 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0619-2021 FDA Class II initiated 25 Nov 2020 on shared 510(k) K130390

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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