Catalog Number

M5-1

Brand Name

Malar Implant

Version/Model Number

Style 5 / Size 1

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

K971479

Product Code

LZK

Product Code Name

Implant, Malar

Public Device Record Key

d73b0a87-f0a8-4d09-b234-efa50267a16c

Public Version Date

November 15, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-