Catalog Number

1162025S

Brand Name

Revolution

Version/Model Number

1162025S

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

K142939

Product Code

NKB

Product Code Name

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Public Device Record Key

9bc80a59-014d-46cb-b853-f08091c57e74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-