Identity
- Trade Name
- iTotal® CR iPoly XE™ Insert Kit FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RCR020110001 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RCR0201100 FDA UDI
- Primary DI / UDI-DI
- M572RCR0201100011 FDA UDI
- FDA Product Code
- JWH FDA UDIOOG FDA UDIOIY FDA UDI
- GMDN Term
- Total knee prosthesis implantation guide-instrument kit 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
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
Dimensions & Sizes
- Size
- Height — 11 Millimeter FDA UDI
iTotal® CR iPoly XE™ Insert Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140423 also covers:
- iTotal® CR Femoral Kit — Conformis, Inc.
- iTotal® CR Tibial Tray 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.
K142161 also covers:
- iTotal® CR Tibial Tray 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 f4e5f19a-22b5-4e3d-9c25-8d3b99caf836 38 fields · synced May 31, 2026