Catalog Number

2107-0118-N

Brand Name

Endoskeleton VBR

Version/Model Number

2107-0118-N

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

K032812,K141953

Product Code

MQP

Product Code Name

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Public Device Record Key

a15d7efe-1c27-4bc7-9342-f034d71fee0b

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

-