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Fitbone Transport and Lengthening System 1

by Orthofix, Inc. 135 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18059015377378 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fitbone Transport and Lengthening System
Generic Name
Long bone distraction intramedullary nail, motorized
Model / Ref / Catalog
1, 99-60003871
Primary DI / UDI-DI
18059015377378
510(k) Number
FDA Product Code
HSB
GMDN Term
Long bone distraction intramedullary nail, motorized
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K260146)

Show all (12)

Other devices from Orthofix, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No