Catalog Number

14-451550

Brand Name

THP™ Hip Fracture Plating System

Version/Model Number

14-451550

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

-

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

K140018,K173826

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

67e2fa09-7f7f-4685-9312-ea7b810c1fe5

Public Version Date

November 04, 2020

Public Version Number

5

DI Record Publish Date

December 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-