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FITBONE® Upgrade Reamer Tray SAA and TAA13 L480

by Wittenstein Intens GmbH

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260170142054 UDI-DIDate2 Jun 2021ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fitbone®
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
Upgrade Reamer Tray SAA and TAA13 L480, 60001629
Primary DI / UDI-DI
04260170142054
FDA Product Code
HSB
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Wittenstein Intens GmbH

  • Fitbone Taa

    Class II

  • Fitbone(R) Taa

    Class II

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No