Catalog Number

MF-LA-1010

Brand Name

PolyLock Midfoot

Version/Model Number

MF-LA-1010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K202959

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

3c56fd62-075a-4644-aa62-c6ea72dc2a17

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-