Catalog Number

TCL-018

Brand Name

Titanium Hip Plate

Version/Model Number

TCL-018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072175

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

97bf6e47-6fc5-4a0d-87b7-90dae9e0ab82

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-