Catalog Number

2106-1009

Brand Name

ENDOSKELETON® TA

Version/Model Number

2106-1009

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 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

K080615

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

a084246d-2123-412c-b905-b2e48243607c

Public Version Date

September 16, 2022

Public Version Number

12

DI Record Publish Date

December 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-