Catalog Number

150-6135-261

Brand Name

3.5 TPO TI polyaxial locking plate, left

Version/Model Number

150-6135-261

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

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

8cd2f1c2-9e5b-44b3-a67d-d0bede363f5f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2016

Package DI Number

EMAH15061352611

Quantity per Package

1

Contains DI Package

EMAH15061352610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-