Catalog Number

3114-3116-S

Brand Name

ENDOSKELETON® TO Sterile Barrier System

Version/Model Number

3114-3116-S

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

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

K102067,K142589

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

0a7f5245-3732-4717-be80-69ebd43fcb2e

Public Version Date

December 09, 2020

Public Version Number

9

DI Record Publish Date

December 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-