Catalog Number

00-1300-3305

Brand Name

Response 5.5/6.0 Spine System

Version/Model Number

00-1300-3305

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

K161267

Product Code

OWI

Product Code Name

Bone fixation cerclage, sublaminar

Public Device Record Key

0f35be8d-f013-4ed6-9eb6-63bbbfd1b694

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-