Catalog Number

4900-1023

Brand Name

ENDOSKELETON® TT

Version/Model Number

4900-1023

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

K083714

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

ff9e568f-95b9-4311-9078-b5bf8bb01a1b

Public Version Date

September 16, 2022

Public Version Number

12

DI Record Publish Date

April 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-