Catalog Number

-

Brand Name

Headless Compression Screw 5.0mm x 36mm

Version/Model Number

HCS 536

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

K170687

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

6ac85faa-1698-40da-b8fb-7a8ae4651060

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-