Catalog Number

00-1300-5016

Brand Name

Response Spine System

Version/Model Number

00-1300-5016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

8b8bb1ea-f520-4e81-8496-37a134ada0bf

Public Version Date

July 21, 2022

Public Version Number

5

DI Record Publish Date

June 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-