Catalog Number

-

Brand Name

Secure Screw 35mm

Version/Model Number

6300-11-35

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

K191771,K191771

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

58f9b0b6-8850-45f7-b59b-114f63b01e43

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

10857915007566

Quantity per Package

5

Contains DI Package

00857915007569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case