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Fitbone Trochanteric 1

by Orthofix SRL 33 variants

Fitbone Trochanteric 1 (7001297) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K250112 on 10 Apr 2025 and listed in FDA GUDID since 24 Jun 2025 (UDI-DI 18059015376401), active as of 12 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K250112

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18059015376401 UDI-DI Date24 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250112 Date10 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250112 decided 10 Apr 2025 Active
  • FDA GUDID UDI-DI 18059015376401 listed 24 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250112
  2. Listed FDA GUDID 18059015376401

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fitbone Trochanteric
Generic name
Bone nail trial, reusable
Model / Ref / Catalog
1, 7001297
Primary DI / UDI-DI
18059015376401
510(k) Number
FDA product code
HSB
GMDN term
Bone nail trial, reusable
Device class
Class II
Regulation number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 297 Millimeter
Outer Diameter — 11 Millimeter

Related devices

Category: Bone nail trial, reusable

Cleared under the same submission (K250112)

and 8 more cleared under K250112

Similar devices

Also classified as Bone nail trial, reusable.

Similar devices

Other devices filed under FDA product code HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES).

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)