Catalog Number

-

Brand Name

ORTHOLOC 3DI PLATING SYSTEM

Version/Model Number

58889003

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"

-

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

K163044

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

b0d58e0a-d76f-44da-ae68-273c5c842f27

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-