Identity
- Trade Name
- VISIONAIRE FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS II FDA UDI
- Model / Reference
- V0100105 FDA UDI
- Description
- VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS II FDA UDI
Identifiers
- Catalog Number
- V0100105 FDA UDI
- Primary DI / UDI-DI
- 00885556656358 FDA UDI
- 510(k) Number
- K170282 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Custom-made orthopaedic/craniofacial surgical guide
Visionaire by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Custom-made orthopaedic/craniofacial surgical guide.
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- Prophecy — MicroPort Orthopedics Inc. · Class II
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Cleared under the same submission
K170282 also covers:
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — Smith & Nephew, Inc.
- VISIONAIRE — 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 6e9c1cb6-6fe5-4afd-a831-27e27d9efd0c 36 fields · synced Jun 8, 2026