Identity
- Trade Name
- Fitbone Trochanteric FDA UDI
- Generic Name
- Long bone distraction intramedullary nail, motorized FDA UDI
- Device Name
- FITBONE TROCHANTERIC NAIL L257MM D11MM STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE TROCHANTERIC NAIL L257MM D11MM STERILE FDA UDI
Identifiers
- Catalog Number
- 99-701257 FDA UDI
- Primary DI / UDI-DI
- 18059015376227 FDA UDI
- 510(k) Number
- K250112 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Long bone distraction intramedullary nail, motorized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 257 Millimeter FDA UDIOuter Diameter — 11 Millimeter FDA UDI
Category: Long bone distraction intramedullary nail, motorized
Fitbone Trochanteric by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Long bone distraction intramedullary nail, motorized.
- ORTHOFIX — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
- FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
- ORTHOFIX — Orthofix, Inc. · Class II
Cleared under the same submission
K250112 also covers:
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
- Fitbone Trochanteric — Orthofix, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI bebb3bc0-3add-4a58-9538-2a20749af6a1 37 fields · synced Jun 8, 2026