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iTotal® Identity Cruciate Retaining Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iTotal® Identity Cruciate Retaining Knee Replacement System FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
ITOTAL IDENTITY CR TIBIAL TRAY (TITANIUM, CEMENTED) FDA UDI
Model / Reference
TCR301111301 FDA UDI
Description
ITOTAL IDENTITY CR TIBIAL TRAY (TITANIUM, CEMENTED) FDA UDI

Identifiers

Catalog Number
TCR3011113 FDA UDI
Primary DI / UDI-DI
M572TCR3011113011 FDA UDI
FDA Product Code
OOG FDA UDI
JWH FDA UDI
OIY 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

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

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI 8313fd5e-ea3c-450a-aff6-8a5cc7d29e9a 35 fields · synced May 30, 2026