Identity
- Trade Name
- Spectron FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- SPECTRON EF GUIDE ROD/BUCK PLUG 35MM FDA UDI
- Model / Reference
- 71367735 FDA UDI
- Description
- SPECTRON EF GUIDE ROD/BUCK PLUG 35MM FDA UDI
Identifiers
- Catalog Number
- 71367735 FDA UDI
- Primary DI / UDI-DI
- 03596010473455 FDA UDI
- FDA Product Code
- LZN FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
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: Surgical drill guide, reusable
Spectron by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
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- Truliant — Exactech, Inc. · Class II
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- Hintermann Series — Dt Medtech, LLC · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
K211176 also covers:
- BUCK — Smith & Nephew, Inc.
- Conquest FX — Smith & Nephew, Inc.
- Contour — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
K791125 also covers:
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- BUCK — Smith & Nephew, Inc.
- PREP-IM — Smith & Nephew, Inc.
- Spectron — Smith & Nephew, Inc.
- Spectron — 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 c78a3143-e8fe-4700-b7a7-6895e2dbc2c5 37 fields · synced Jun 8, 2026