Catalog Number

OS722027-NS

Brand Name

Volition™ Plating System

Version/Model Number

OS722027-NS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202764

Product Code

HTW

Product Code Name

Bit, Drill

Public Device Record Key

396d3a08-a3b3-49f8-ba11-8a227d5eba23

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-