Identity
- Trade Name
- PRECICE® Instruments FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Orthopedic surgical instrument - Locking Bolt, Short FDA UDI
- Model / Reference
- LBT2-001 FDA UDI
- Description
- Orthopedic surgical instrument - Locking Bolt, Short FDA UDI
Identifiers
- Catalog Number
- LBT2-001 FDA UDI
- Primary DI / UDI-DI
- 00812258028916 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
No
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: Orthopaedic bone screw, non-bioabsorbable, non-sterile
PRECICE® Instruments by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 69f9945b-6d82-420b-8dc6-7f017796021e 36 fields · synced May 31, 2026