Catalog Number

-

Brand Name

ENDOSKELETON® TCS Sterile Barrier System

Version/Model Number

5303-1405-S

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

Yes

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

K191565

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Public Device Record Key

fda2cae0-b82b-4ad4-ae35-a4abd517d162

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-