Catalog Number

215-21012

Brand Name

N/A

Version/Model Number

215-21012

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

K190391

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

9df35ebf-3e3d-44c9-93a9-1e0aa6e22204

Public Version Date

October 06, 2021

Public Version Number

2

DI Record Publish Date

November 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-