Catalog Number

-

Brand Name

VersaTie

Version/Model Number

8510260

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K161265

Product Code

OWI

Product Code Name

Bone fixation cerclage, sublaminar

Public Device Record Key

752f7fb8-3238-4e76-b81b-7f62ca8b5d88

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-