Catalog Number

E631012R

Brand Name

Evolution Revision CCK System

Version/Model Number

E631012R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171389

Product Code

PBF

Product Code Name

Orthopaedic surgical planning and instrument guides

Public Device Record Key

9d95bc71-fd2d-4b3a-9fe2-b324d260463a

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-