Catalog Number

150-4300-116

Brand Name

2.0mm LCP (TM) condylar Plate 7 Holes

Version/Model Number

150-4300-116

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

88b267f6-7353-4270-9011-8650af691990

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2016

Package DI Number

EMAH15043001161

Quantity per Package

1

Contains DI Package

EMAH15043001160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-