Catalog Number

-

Brand Name

Fixed-Angle Reduction Screw

Version/Model Number

8248555

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 2017

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

K160320

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

1498e9b8-210c-45f3-a36e-fa5d2c3b3097

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-