Catalog Number

2301-0007

Brand Name

ENDOSKELETON® TAS

Version/Model Number

2301-0007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2020

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

98b638ff-ed9f-4af0-bb09-1962062ba8fc

Public Version Date

October 21, 2022

Public Version Number

3

DI Record Publish Date

September 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-