Identity
- Trade Name
- PRECICE® Trauma Nail System FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- Locking Bolt, Tibia Jig FDA UDI
- Model / Reference
- LBT1-000 FDA UDI
- Description
- Locking Bolt, Tibia Jig FDA UDI
Identifiers
- Catalog Number
- LBT1-000 FDA UDI
- Primary DI / UDI-DI
- 00812258027209 FDA UDI
- 510(k) Number
- K160267 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Tibia 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Tibia intramedullary nail
PRECICE® Trauma Nail System by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tibia intramedullary nail.
- Natural Nail® — Zimmer, Inc. · Class II
- Affixus® — Zimmer, Inc. · Class II
- Affixus® — Zimmer, Inc. · Class II
- TRIGEN MAX — Smith & Nephew, Inc. · Class II
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD · Class II
- AJAX Nail — Auxein Medical Private Limited · Class II
- ESTREMO — Citieffe · Class II
- PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
Cleared under the same submission
K160267 also covers:
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc.
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, 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
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI fa7dc5b9-d1f1-4cc0-9037-c87406c75b53 37 fields · synced May 31, 2026