Catalog Number

MHP004

Brand Name

ORTHOLOC™ SPS

Version/Model Number

MHP004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

-

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

-

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

b4dc1d32-55b5-493b-9388-5fd1d25da805

Public Version Date

September 26, 2022

Public Version Number

3

DI Record Publish Date

December 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-