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Identity Imprint Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
Identity Imprint Knee Replacement System FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
PS TIBIAL TRAY SIZE 2 NARROW FDA UDI
Model / Reference
TPS301T02N01 FDA UDI
Description
PS TIBIAL TRAY SIZE 2 NARROW FDA UDI

Identifiers

Catalog Number
TPS-301-T02N FDA UDI
Primary DI / UDI-DI
M572TPS301T02N011 FDA UDI
510(k) Number
K210191 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

Identity Imprint 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.

Cleared under the same submission

K210191 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 a7aa2c70-566c-45ff-ae6a-21ec3c6f6c8d 37 fields · synced May 30, 2026