Identity
- Trade Name
- ADVANCE® FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- ADVANCE® II REVISION CCK INSERT SIZE 3 MINUS 20mm FDA UDI
- Model / Reference
- KIRV320M FDA UDI
- Description
- ADVANCE® II REVISION CCK INSERT SIZE 3 MINUS 20mm FDA UDI
Identifiers
- Catalog Number
- KIRV320M FDA UDI
- Primary DI / UDI-DI
- M684KIRV320M1 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Posterior-stabilized total knee prosthesis 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 20 Millimeter FDA UDI
Category: Posterior-stabilized total knee prosthesis
Advance® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Posterior-stabilized total knee prosthesis.
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- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
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- Tibial Revision Platform — CPM Medical Consultants, LLC · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, 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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 7dd70d4c-b8d0-40fb-b226-b3a59549b6c6 36 fields · synced Jun 9, 2026