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Tibial Revision Platform

FDA UDI

Class II (US FDA UDI)

by CPM Medical Consultants, LLC

Identity

Trade Name
Tibial Revision Platform FDA UDI
Generic Name
Posterior-stabilized total knee prosthesis FDA UDI
Device Name
Stem 18mm x 75mm - Press-Fit FDA UDI
Model / Reference
Rev A FDA UDI
Description
Stem 18mm x 75mm - Press-Fit FDA UDI

Identifiers

Catalog Number
M-3202-1875 FDA UDI
Primary DI / UDI-DI
B565M320218750 FDA UDI
510(k) Number
K210695 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Posterior-stabilized total knee prosthesis 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Posterior-stabilized total knee prosthesis

Tibial Revision Platform by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-stabilized total knee prosthesis.

Cleared under the same submission

K210695 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CPM Medical Consultants, LLC

Sources (1)

  • FDA UDI c7aa79a6-32c9-4efe-aede-82edd842692d 36 fields · synced Jun 1, 2026