Catalog Number

150-6127-106

Brand Name

2.7 LC TI polyaxial locking plate, str.,6 h.,57mm

Version/Model Number

150-6127-106

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

6d1e3ef8-a325-445e-8e8b-3e52c14e3b15

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2016

Package DI Number

EMAH15061271061

Quantity per Package

1

Contains DI Package

EMAH15061271060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-