Catalog Number

150-6635-044PTXL

Brand Name

TI 3.5mm mono-/polyaxial locking screw, L.44mm

Version/Model Number

150-6635-044PTXL

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"

Yes

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

-

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

a6dd4a16-85fd-4d12-8458-cc3f51e5ef54

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2016

Package DI Number

EMAH1506635044PTXL1

Quantity per Package

1

Contains DI Package

EMAH1506635044PTXL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-