Catalog Number

27-4000-008

Brand Name

Preference 2

Version/Model Number

B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K081883

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

89b0e4b5-4680-4823-aa2d-3246d1c0ce04

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-