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Evolution Revision CCK System

FDA UDI

Class I (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name
Evolution Revision CCK System FDA UDI
Generic Name
Joint prosthesis implantation kit, reusable FDA UDI
Model / Reference
E215XRCM FDA UDI

Identifiers

Catalog Number
E215XRCM FDA UDI
Primary DI / UDI-DI
M684E215XRCM1 FDA UDI
510(k) Number
K171389 FDA UDI
FDA Product Code
HWT FDA UDI
PBF FDA UDI
GMDN Term
Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

A comprehensive orthopedic surgical system designed for joint replacement and revision procedures. The Evolution Revision CCK System is a reliable and efficient solution for surgeons, providing precise control and high-quality results.

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Cleared under the same submission

K171389 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroPort Orthopedics Inc.

Sources (1)

  • FDA UDI f05a90fb-d8ca-4a53-afef-15f70ff0831f 35 fields · synced Jul 19, 2026