Catalog Number

003-E-00001R

Brand Name

VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 2019

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

K140876

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

5012c481-f9dc-4ea9-a4ab-bfc8b2fd13ac

Public Version Date

October 29, 2019

Public Version Number

4

DI Record Publish Date

June 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-