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iDuo® Patella

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iDuo® Patella FDA UDI
Generic Name
Polyethylene patella prosthesis FDA UDI
Device Name
N/A FDA UDI
Model / Reference
PAB011350702 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
PAB0113507 FDA UDI
Primary DI / UDI-DI
M572PAB0113507021 FDA UDI
510(k) Number
K093513 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Polyethylene patella prosthesis 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 35 Millimeter FDA UDI

iDuo® Patella by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093513 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 def00308-3da2-4a25-9ee7-ca199f115bc2 38 fields · synced May 31, 2026