Identity
- Trade Name
- PRECICE® Intramedullary Limb Lengthening System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 5.0 mm Threaded Locking Screw 35 mm Length FDA UDI
- Model / Reference
- TSA5-035 FDA UDI
- Description
- 5.0 mm Threaded Locking Screw 35 mm Length FDA UDI
Identifiers
- Catalog Number
- TSA5-035 FDA UDI
- Primary DI / UDI-DI
- 00812258027780 FDA UDI
- 510(k) Number
- K160267 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 5.0 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
PRECICE® Intramedullary Limb Lengthening System by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · 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 c7f733b0-910b-4c12-a02a-71b45172427e 37 fields · synced May 30, 2026