Catalog Number

1000-0133

Brand Name

ENDOSKELETON® TL

Version/Model Number

1000-0133

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

K140055

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

c8a54f97-fc0c-408d-87f2-d400edc1d423

Public Version Date

December 09, 2020

Public Version Number

4

DI Record Publish Date

November 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-