Identity
- Trade Name
- CORI FDA UDI
- Generic Name
- Orthopaedic knee-balance analyser, electrically-powered FDA UDI
- Device Name
- CORI KNEE TENSIONER FDA UDI
- Model / Reference
- ROB10100 FDA UDI
- Description
- CORI KNEE TENSIONER FDA UDI
Identifiers
- Catalog Number
- ROB10100 FDA UDI
- Primary DI / UDI-DI
- 00885556809600 FDA UDI
- 510(k) Number
- K221224 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic knee-balance analyser, electrically-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic knee-balance analyser, electrically-powered
Cori by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K221224 also covers:
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 7e8a0397-9b86-4c35-872d-3e0803102935 36 fields · synced Jun 6, 2026