Identity
- Trade Name
- TRIGEN FDA UDI
- Generic Name
- Orthopaedic bone-reduction tool FDA UDI
- Device Name
- REDUCER FDA UDI
- Model / Reference
- 71674077 FDA UDI
- Description
- REDUCER FDA UDI
Identifiers
- Catalog Number
- 71674077 FDA UDI
- Primary DI / UDI-DI
- 03596010560735 FDA UDI
- 510(k) Number
- K122170 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone-reduction tool 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone-reduction tool
Trigen by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone-reduction tool.
- REDUCTION TOOL SMALL BONE NAIL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
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- PRECICE® Trauma Nail System — NuVasive Specialized Orthopedics, Inc. · Class I
- Reduction Rod — Double Medical Technology Inc. · Class II
- MULTILOC — Synthes · Class II
- CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM — Orthofix, Inc. · Class II
- PRECICE® Trauma Intramedullary Nail System Instrument — NuVasive Specialized Orthopedics, Inc. · Class I
- VARIAX — Stryker Corp. · Class I
Cleared under the same submission
K122170 also covers:
- Cannulated Screws — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- INTERTAN — Smith & Nephew, Inc.
- InterTAN — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 0a33b5f8-4764-4eaa-ab64-90c36fe2038d 36 fields · synced Jun 7, 2026