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APEX Revision Knee KC-52502

by OMNIlife science, Inc.

APEX Revision Knee KC-52502 is a Class II device made by OMNIlife science, Inc., listed in FDA GUDID since 27 Nov 2015 (UDI-DI 00841690124405), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841690124405 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
APEX Revision Knee
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
KC-52502
Primary DI / UDI-DI
00841690124405
FDA product code
MBH, JWH
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3565, 888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

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Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)