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Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)

by Omnlife Science

510(k) K112779

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 · Special NumberK112779 Date2 Dec 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2445-2015 FDA Class II initiated 4 Jun 2015

    The device may have improper screw hole placement due to inaccurate location of the index line.

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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