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iTotal® Identity Cruciate Retaining Knee Replacement System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- iTotal® Identity Cruciate Retaining Knee Replacement System FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- ITOTAL IDENTITY CR HYBRID JIGS FDA UDI
- Model / Reference
- TCR000SPEC01 FDA UDI
- Description
- ITOTAL IDENTITY CR HYBRID JIGS FDA UDI
Identifiers
- Catalog Number
- TCR000SPEC FDA UDI
- Primary DI / UDI-DI
- M572TCR000SPEC011 FDA UDI
- FDA Product Code
- OIY FDA UDIOOG FDA UDIJWH FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
iTotal® Identity Cruciate Retaining Knee Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Conformis, Inc.
Sources (1)
- FDA UDI 80b191df-61f0-4614-8cb3-13d9cde744c5 36 fields · synced Jun 6, 2026