Catalog Number

4300

Brand Name

Collagen Meniscus Implant CMI®

Version/Model Number

Medial 7.5 mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2018

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

Yes

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

-

Product Code

OLC

Product Code Name

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Public Device Record Key

a7bc39b0-2c6c-4a1b-a1dd-417c69398574

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-