Catalog Number

-

Brand Name

DynaNail Helix, Headless, 55mm

Version/Model Number

3200-01-7055

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

K203595

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

1eed9494-ebdb-47ed-b9ea-baff63f4f281

Public Version Date

April 26, 2022

Public Version Number

1

DI Record Publish Date

April 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-