Catalog Number

-

Brand Name

2.7mm x 8mm Ti Locking Screw

Version/Model Number

TLK27008-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

7393b3cd-be7d-41e3-ac16-c3361e298abd

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-