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APEX Knee System XK-03035

by OMNIlife science, Inc.

APEX Knee System XK-03035 is a Class I device made by OMNIlife science, Inc., listed in FDA GUDID since 29 Dec 2022 (UDI-DI 00841690183495), 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 Number00841690183495 UDI-DI Date29 Dec 2022ListedStatusListed 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  • Withdrawn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 Knee System
Generic name
Joint prosthesis implantation kit, reusable
Model / Ref / Catalog
XK-03035
Primary DI / UDI-DI
00841690183495
FDA product code
FZX
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Joint prosthesis implantation kit, reusable

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)