iTotal CR

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: iTotal CR FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: ITOTAL CR–IPOLY XE–16MM MEDIAL INSERT KIT–LEFT or right FDA UDI
Model / Reference: RCR-020-160003 FDA UDI
Description: ITOTAL CR–IPOLY XE–16MM MEDIAL INSERT KIT–LEFT or right FDA UDI

Identifiers

Catalog Number: RCR-020-1600 FDA UDI
Primary DI / UDI-DI: M572RCR0201600031 FDA UDI
FDA Product Code: JWH FDA UDI
OIY FDA UDI
OOG FDA UDI
GMDN Term: Tibial insert 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibial insert

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

Similar devices

Also classified as Tibial insert.

DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
P.F.C. SIGMA — DEPUY (IRELAND) · Class II
Truliant, Activit-E — Exactech, Inc. · Class II
Maxim Knee System — Biomet Orthopedics, Inc. · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

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 32b10319-16f5-47a9-929b-8a84d5b8e124 36 fields · synced May 30, 2026