Catalog Number

-

Brand Name

TSRH® Spinal System

Version/Model Number

8379131C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2018

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

K022778

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Public Device Record Key

865d8d11-7a11-4203-8ee7-7107153f569d

Public Version Date

February 06, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-