Catalog Number

2312-1117-S

Brand Name

Endoskeleton TAS

Version/Model Number

2312-1117-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2020

Issuing Agency

In HIBCC

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

K111626,K142589

Product Code

OVD

Product Code Name

Intervertebral fusion device with integrated fixation, lumbar

Public Device Record Key

65ad8497-ad90-4d46-8e2f-8450bca8ec6a

Public Version Date

December 09, 2020

Public Version Number

7

DI Record Publish Date

September 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-