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iTotal® CR iPoly® XE Insert Kit

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iTotal® CR iPoly® XE Insert Kit FDA UDI
Generic Name
Tibial insert FDA UDI
Device Name
N/A FDA UDI
Model / Reference
RCR020000H13 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
RCR020000H FDA UDI
Primary DI / UDI-DI
M572RCR020000H131 FDA UDI
510(k) Number
K153721 FDA UDI
K161366 FDA UDI
FDA Product Code
OIY FDA UDI
OOG FDA UDI
JWH FDA UDI
GMDN Term
Tibial insert 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

Yes

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 iPoly® XE Insert Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153721 also covers:

K161366 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 1dfe261e-28c9-4831-8d5d-1b6458eec261 38 fields · synced May 30, 2026