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Fitbone® Scho M2 L325

by Wittenstein Intens GmbH GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260170140654 UDI-DIDate12 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Fitbone®
Generic Name
Surgical implant/trial-implant/sizer holder, reusable
Model / Ref / Catalog
SCHO M2 L325, 60000384
Primary DI / UDI-DI
04260170140654
FDA Product Code
HSB
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable
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
  • 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