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Rotaglide+ Modular Knee System with Fixed Meniscus

FDA UDI

Class II (US FDA UDI)

by Corin Ltd

Identity

Trade Name
Rotaglide+ Modular Knee System with Fixed Meniscus FDA UDI
Generic Name
Coated knee femur prosthesis FDA UDI
Device Name
RTK+ STEM FEMUR FDA UDI
Model / Reference
102.010P FDA UDI
Description
RTK+ STEM FEMUR FDA UDI

Identifiers

Catalog Number
102.010P FDA UDI
Primary DI / UDI-DI
05055196915114 FDA UDI
510(k) Number
K000232 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Coated knee femur 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Coated knee femur prosthesis

Rotaglide+ Modular Knee System with Fixed Meniscus by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated knee femur prosthesis.

Cleared under the same submission

K000232 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corin Ltd

Sources (1)

  • FDA UDI 856c6768-a062-4f9c-83d7-1d19b6f48506 36 fields · synced May 31, 2026