← Back to catalogue

Identity Imprint Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
Identity Imprint Knee Replacement System FDA UDI
Generic Name
Total knee prosthesis implantation guide-instrument kit FDA UDI
Device Name
CR REPLACEMENT TIBIAL TRAY JIGS, LEFT AND RIGHT FDA UDI
Model / Reference
TCR000D00301 FDA UDI
Description
CR REPLACEMENT TIBIAL TRAY JIGS, LEFT AND RIGHT FDA UDI

Identifiers

Catalog Number
TCR-000-D003 FDA UDI
Primary DI / UDI-DI
M572TCR000D003011 FDA UDI
510(k) Number
K210191 FDA UDI
FDA Product Code
JWH FDA UDI
OIY FDA UDI
OOG 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
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

Category: Total knee prosthesis implantation guide-instrument kit

Identity Imprint Knee Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total knee prosthesis implantation guide-instrument kit.

Cleared under the same submission

K210191 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI 8c849c89-6f1d-40a8-985f-9bb7cbf5f214 36 fields · synced May 30, 2026