Catalog Number

-

Brand Name

11 Hole Contoured VL Gridlock Fibula Plate

Version/Model Number

300-61-003

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"

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

K160177

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

ce16eb30-8f0d-49c0-a91b-5465d04d89c6

Public Version Date

April 06, 2022

Public Version Number

4

DI Record Publish Date

March 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-