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APEX Knee System XK80001

by OMNIlife science, Inc.

APEX Knee System XK80001 is a Class I device made by OMNIlife science, Inc., listed in FDA GUDID since 27 Mar 2023 (UDI-DI 00841690182771), 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 Number00841690182771 UDI-DI Date27 Mar 2023ListedStatusListed 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  • Withdrawn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
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
XK80001
Primary DI / UDI-DI
00841690182771
FDA product code
HWT
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class I
Regulation number
888.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Knee tibia prosthesis trial, reusable

Other devices from OMNIlife science, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)