Catalog Number

-

Brand Name

DynaClip Bone Fixation System, Quattro, 22mm x 20mm x 20mm

Version/Model Number

3000-11-222020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K220812

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

e9a809ce-63c6-4ac4-a0ae-7a70c20c4fe6

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-