Catalog Number

-

Brand Name

Morphix

Version/Model Number

1000-03-345

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K091202

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

e46e3b6e-d048-4e5f-b87f-f5efa13e3e29

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

May 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-