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Fitbone® Fakn L400

by Wittenstein Intens GmbH

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04260170140708 UDI-DI Date12 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Tendon stripper
Model / Ref / Catalog
FAKN L400, 60001297
Primary DI / UDI-DI
04260170140708
510(k) Number
FDA Product Code
HSB
GMDN Term
Tendon stripper
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K163368)

Show all (12)

Other devices from Wittenstein Intens GmbH

  • Fitbone Taa

    Class II

  • Fitbone(R) Taa

    Class II

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No