Identity
- Trade Name
- TRIGEN FDA UDI
- Generic Name
- Cannulated surgical drill guiding pin FDA UDI
- Device Name
- 3.2MM X 343MM BRAD POINT TIP THREADED GUIDE PIN FDA UDI
- Model / Reference
- 71674130 FDA UDI
- Description
- 3.2MM X 343MM BRAD POINT TIP THREADED GUIDE PIN FDA UDI
Identifiers
- Catalog Number
- 71674130 FDA UDI
- Primary DI / UDI-DI
- 00885556131879 FDA UDI
- 510(k) Number
- K123055 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Cannulated surgical drill guiding pin 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cannulated surgical drill guiding pin
Trigen by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill guiding pin.
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
- Implant-One — Implant Logistics, Inc. · Class I
- EPIC CANNULATED SCREW SYSTEM — Exactech, Inc. · Class II
- Superhawk — RESPONSIVE ORTHOPEDICS LLC · Class I
- GUIDE PIN 2.8 BL & 3.2 PL — Biomet Orthopedics, Inc. · Class II
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
- JUGGERLOC 2.9MM GUIDE PIN — Biomet Orthopedics, Inc. · Class II
- Hyper-C — Degen Medical · Class I
Cleared under the same submission
K123055 also covers:
- BIRMINGHAM HIP RESURFACING(BHR) — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- Jet-X — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LEGION — 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 f19b9171-a1b9-45c1-bb07-3e64f8d47e5d 36 fields · synced Jun 8, 2026