Catalog Number

1000-0068

Brand Name

ENDOSKELETON® TAS

Version/Model Number

1000-0068

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

-

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

K111626

Product Code

OVD

Product Code Name

Intervertebral fusion device with integrated fixation, lumbar

Public Device Record Key

d50d83b0-828b-472a-a5c2-857665de2759

Public Version Date

December 09, 2020

Public Version Number

2

DI Record Publish Date

November 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-