Catalog Number

DF200040

Brand Name

DOLPHIX

Version/Model Number

Clamp with bone screw ø6mm L200mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2018

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

K132363

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

6a3ffc28-b920-47da-b27f-78d834897529

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-