Catalog Number

494772

Brand Name

NA

Version/Model Number

494.772

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K082650,K963618,K952296,K122455

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

4e85d4c0-b405-46ab-a220-b64766ee2d68

Public Version Date

April 29, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-