Catalog Number

OM 71-0675R

Brand Name

ORTHOMED

Version/Model Number

OM 71-0675R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102845,K102845

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

b0986ac2-c590-462c-b783-76107694a595

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Package DI Number

B8037106753

Quantity per Package

6

Contains DI Package

B803710675R0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

TUBE