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Fitbone Taa System 1

by Orthofix, Inc. 141 variants

Ref 60001055Model VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of intramedullary nails

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) K163368

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 Number805050436NStInsNail2a25E7 Basic UDI-DI 18053340343633UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18053340343633 UDI-DI Date12 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163368 Date26 Jan 2017DecidedStatusActive

Official records

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  • Withdrawn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
Fitbone Taa System GUDID
Generic name
Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog
VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of intramedullary nails, 60001055, 1
Primary DI / UDI-DI
18053340343633
Basic UDI-DI
805050436NStInsNail2a25E7
510(k) Number
FDA product code
HSB
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe
Size
Outer Diameter — 13 Millimeter
Lumen/Inner Diameter — 12 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic implantation sleeve, reusable

Cleared under the same submission (K163368)

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