Identity
- Trade Name
- PRECICE® Intramedullary Limb Lengthening System FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 12.5 mm diameter, 230 mm length FDA UDI
- Model / Reference
- PR12.5-50D230 FDA UDI
- Description
- Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 12.5 mm diameter, 230 mm length FDA UDI
Identifiers
- Catalog Number
- PR12.5-50D230 FDA UDI
- Primary DI / UDI-DI
- 00812258024758 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur intramedullary nail 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
Yes
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
- Outer Diameter — 12.5 Millimeter FDA UDI
Category: Femur intramedullary nail
The PRECICE Intramedullary Limb Lengthening System is a medical device designed to assist orthopedic surgeons in lengthening fractured femur ends. By providing a rigid rod made of metal or other material, this system helps to immobilize the bone in position and promote healing.
Similar devices
Also classified as Femur intramedullary nail.
- GAMMA — Stryker Corp. · Class II
- A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- T2 ALPHA — Stryker Corp. · Class II
- T2 — Stryker Corp. · Class II
- 130° Ga-mma Nail — Auxein Medical Private Limited · Class II
- ARIX Femur Nail System — Jeil Medical Corporation · Class II
- INTERTAN — Smith & Nephew, Inc. · Class II
- TRIGEN — Smith & Nephew, Inc. · Class II
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
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI d08cc01b-3d5f-44e6-931c-682f7a97192d 36 fields · synced Jun 19, 2026