Catalog Number

-

Brand Name

Anterial Lateral Tibia Plate 4 Hole Left

Version/Model Number

20645

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

K162674

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

7700c9aa-0bfe-4db8-a004-0d5f9244af2e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-