Identity
- Trade Name
- iTotal® CR Tibial Tray Kit FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, metallic FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RCR101111301 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RCR1011113 FDA UDI
- Primary DI / UDI-DI
- M572RCR1011113011 FDA UDI
- 510(k) Number
- K120068 FDA UDI
- FDA Product Code
- OOG FDA UDIJWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, metallic 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
Yes
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
MR Conditional FDA UDI
Category: Uncoated knee tibia prosthesis, metallicTotal knee prosthesis implantation guide-instrument kit
iTotal® CR Tibial Tray Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total knee prosthesis implantation guide-instrument kit.
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Cleared under the same submission
K120068 also covers:
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
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
- Conformis, Inc.
Sources (1)
- FDA UDI b12d3e35-df09-4949-914a-d64b3efae9b7 37 fields · synced Jun 6, 2026