Catalog Number

497668

Brand Name

NA

Version/Model Number

497.668

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

K981275,K981275,K961421,K033975,K033975,K961421

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

62c9a213-bc92-428e-8110-8a29aa81d5d8

Public Version Date

April 25, 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

-