Identity
- Trade Name
- EVOS FDA UDI
- Generic Name
- Total wrist radius prosthesis FDA UDI
- Device Name
- EVOS DORSAL WRIST SPANNING PLATE 13H 187MM TITANIUM FDA UDI
- Model / Reference
- 71158508 FDA UDI
- Description
- EVOS DORSAL WRIST SPANNING PLATE 13H 187MM TITANIUM FDA UDI
Identifiers
- Catalog Number
- 71158508 FDA UDI
- Primary DI / UDI-DI
- 00885556780541 FDA UDI
- 510(k) Number
- K213123 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Total wrist radius prosthesis 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: Total wrist radius prosthesis
Evos by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total wrist radius prosthesis.
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
- Maestro™ Total Wrist — Biomet Orthopedics, Inc. · Class II
- Maestro™ Total Wrist — Biomet Orthopedics, Inc. · Class II
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
- MAESTRO TOTAL WRIST — Biomet Orthopedics, Inc. · Class II
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 7f07823e-9173-4e3f-8f4a-3b654fa3ee96 36 fields · synced Jun 8, 2026