Catalog Number

TLK35040

Brand Name

3.5mm x 40mm Ti Locking Screw

Version/Model Number

TLK35040-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

4d12d7cd-ee93-4bb6-804b-8b4cc78c2b02

Public Version Date

January 17, 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

-