Catalog Number

TCX35014

Brand Name

3.5mm x 14mm Ti Cortical Screw

Version/Model Number

TCX35014-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K180736

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

889d0d87-4bb2-46ac-85bc-dcb8de96f720

Public Version Date

January 14, 2022

Public Version Number

2

DI Record Publish Date

November 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-