Catalog Number

10001

Brand Name

NA

Version/Model Number

10001

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

K083619

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

da20bac8-7af8-40ba-b3e2-d523c8f6a61f

Public Version Date

March 21, 2019

Public Version Number

6

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-