Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-18053340344838 Basic UDI-DI 18053340344838UDI-DI	Date6 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number18053340344838 UDI-DI	Date12 Apr 2023Listed	StatusListed GUDID: in commercial distribution

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 25 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Stainless Steel Femoral Nailing System EUDAMED
Fitbone Taa System GUDID
Generic Name: Medullary canal orthopaedic reamer, rigid
Model / Ref / Catalog: 60001848, 1

Primary DI / UDI-DI: 18053340344838
Basic UDI-DI: B-18053340344838
510(k) Number: K203399
FDA Product Code: HSB
EMDN Code: Z12139099 Various orthopaedic and traumatology instruments - other
GMDN Term: Medullary canal orthopaedic reamer, rigid

Device Class: Class IIa EUDAMED
Class II GUDID
Regulation Number: 888.3020
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Unsafe

Size: Length — 300 Millimeter
Outer Diameter — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED 60001848	GUDID 1
Device Class	EUDAMED Class IIa	GUDID Class II

Category: Medullary canal orthopaedic reamer, rigid

Cleared under the same submission (K203399)

Show all (12)

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Properties

Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (21)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No