Skip to content

APEX Knee System XK-00022

by OMNIlife science, Inc.

APEX Knee System XK-00022 is a Class I device made by OMNIlife science, Inc., listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690183792), 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 Number00841690183792 UDI-DI Date10 Jan 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  • Withdrawn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
Orthopaedic osteotome
Model / Ref / Catalog
XK-00022
Primary DI / UDI-DI
00841690183792
FDA product code
GFI
GMDN term
Orthopaedic osteotome
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic osteotome

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)