Identity
- Trade Name
- ORTHOSPHERE FDA UDI
- Generic Name
- Total wrist carpal articulation prosthesis FDA UDI
- Model / Reference
- 8530010 FDA UDI
Identifiers
- Catalog Number
- 8530010 FDA UDI
- Primary DI / UDI-DI
- 00840420121776 FDA UDI
- FDA Product Code
- KWD FDA UDI
- GMDN Term
- Total wrist carpal articulation prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3730 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDI
Category: Total wrist carpal articulation prosthesis
Orthosphere by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total wrist carpal articulation 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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI 58c90665-64e5-4f40-b04a-5bd0ef7dfc80 35 fields · synced Jun 7, 2026