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Instrument 5537-T-425X

by Howmedica Osteonics Corp.

Instrument 5537-T-425X is a Class I device made by Howmedica Osteonics Corp., listed in FDA GUDID since 25 Jul 2023 (UDI-DI 07613327520835), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327520835 UDI-DI Date25 Jul 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  • Withdrawn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
Instrument
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
5537-T-425X
Primary DI / UDI-DI
07613327520835
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 Howmedica Osteonics Corp.

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Properties

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