Catalog Number

-

Brand Name

Large Fragment Active Plating System

Version/Model Number

00-505-000-28

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2017

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

K142938

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

4b1e43da-2d4f-42a2-a880-838af460c1cc

Public Version Date

August 13, 2020

Public Version Number

4

DI Record Publish Date

February 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-