Identity
- Trade Name
- VLP FOOT FDA UDI
- Generic Name
- Orthopaedic fixation plate tensioner FDA UDI
- Device Name
- DISTRACTION INSTRUMENT FDA UDI
- Model / Reference
- 71174052 FDA UDI
- Description
- DISTRACTION INSTRUMENT FDA UDI
Identifiers
- Catalog Number
- 71174052 FDA UDI
- Primary DI / UDI-DI
- 00885556279069 FDA UDI
- 510(k) Number
- K120871 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic fixation plate tensioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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 fixation plate tensioner
Vlp Foot by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate tensioner.
- Made-To-Order — TORNIER, INC. · Class I
- Tornier Flex — TORNIER, INC. · Class I
- Tornier Flex — TORNIER, INC. · Class I
- TENSIONER HEAD, CANNULATED — Biomet Orthopedics, Inc. · Class I
- LARGE FRAG TENSIONER — Biomet Orthopedics, Inc. · Class I
- Apelo® / Apelo® MIS — ATLAS SPINE INC. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Aequalis Resurfacing Head — TORNIER, INC. · Class I
Cleared under the same submission
K120871 also covers:
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- CALANDRUCCIO II — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — 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 877946d5-1f24-4244-a729-06d27eb9049f 36 fields · synced Jun 8, 2026