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iTotal® CR Tibial Tray Kit

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iTotal® CR Tibial Tray Kit FDA UDI
Generic Name
Total knee prosthesis implantation guide-instrument kit FDA UDI
Device Name
N/A FDA UDI
Model / Reference
RCR101111302 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
RCR1011113 FDA UDI
Primary DI / UDI-DI
M572RCR1011113021 FDA UDI
510(k) Number
K120316 FDA UDI
FDA Product Code
OOG FDA UDI
JWH 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
MRI Safety
MR Conditional FDA UDI

iTotal® CR Tibial Tray Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K120316 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI 3cb56f32-984d-4627-8b8c-8a9cde988b83 38 fields · synced May 30, 2026