Catalog Number

BIO11012

Brand Name

CoCr Low Profile Cable System

Version/Model Number

1.5mm Cable

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

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

K951844

Product Code

JDQ

Product Code Name

Cerclage, Fixation

Public Device Record Key

7b51c1aa-9d2d-4cb4-aada-ac4438fe027a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-