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iUni® Unicondylar Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iUni® Unicondylar Knee Replacement System FDA UDI
Generic Name
Unicondylar knee prosthesis FDA UDI
Device Name
N/A FDA UDI
Model / Reference
UKA111111101 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
UKA1111111 FDA UDI
Primary DI / UDI-DI
M572UKA1111111011 FDA UDI
510(k) Number
K132640 FDA UDI
FDA Product Code
OOG FDA UDI
HSX FDA UDI
GMDN Term
Unicondylar knee prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3520 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K132640 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 71828173-8059-4d2d-ac22-a03204fbbce8 38 fields · synced May 30, 2026