Catalog Number

5301-3519-S

Brand Name

ENDOSKELETON® TCS Sterile Barrier System

Version/Model Number

5301-3519-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2021

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

K151596,K173535

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

8675e6c2-df93-48e3-aba5-e633b207c4eb

Public Version Date

October 21, 2022

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

-