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Fragment Fixation System 1

by Orthofix, Inc. 6 variants

Ref W1001Model VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion or extraction of orthopaedic devices intended to provide bone fixation

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944092

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436NStIntIns2a25CA Basic UDI-DI 18032568865240UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18032568865240 UDI-DI Date8 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944092 Date4 Apr 1995DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Orthofix Surgical Instruments EUDAMED
Fragment Fixation System GUDID
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion or extraction of orthopaedic devices intended to provide bone fixation, W1001, 1
Primary DI / UDI-DI
18032568865240
Basic UDI-DI
805050436NStIntIns2a25CA
510(k) Number
FDA product code
JEC
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 153 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K944092)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (21)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No