Identity
- Trade Name
- TRIGEN FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- TRIGEN KNEE NAIL GOLD 13MM X 25CM SUPRACONDYLAR FDA UDI
- Model / Reference
- 71633425 FDA UDI
- Description
- TRIGEN KNEE NAIL GOLD 13MM X 25CM SUPRACONDYLAR FDA UDI
Identifiers
- Catalog Number
- 71633425 FDA UDI
- Primary DI / UDI-DI
- 03596010406002 FDA UDI
- FDA Product Code
- JDS FDA UDI
- GMDN Term
- Tibia intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Category: Tibia intramedullary nail
Trigen by Smith & Nephew, 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
- 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
- PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
Cleared under the same submission
K210980 also covers:
- InterTan — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
K981529 also covers:
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — Smith & Nephew, Inc.
- TRIGEN — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 6d7d2d3f-34f6-406e-9cbf-69318a5aea89 36 fields · synced Jun 8, 2026