Catalog Number

14-451564

Brand Name

THP™ Hip Fracture Plating System

Version/Model Number

14-451564

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

K173826

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

05511500-b1c9-4fc8-8819-eda2f7f3cb5f

Public Version Date

November 04, 2020

Public Version Number

2

DI Record Publish Date

March 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-