Volition Plating System - 3.5MM X 36MM HEADLESS CANNULATED SCREW PARTIALLY - ORTHO SOLUTIONS HOLDINGS LIMITED

Duns Number:218648211

Device Description: 3.5MM X 36MM HEADLESS CANNULATED SCREW PARTIALLY THREADED

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More Product Details

Catalog Number

OS741036-NS

Brand Name

Volition Plating System

Version/Model Number

OS741036-NS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K163489

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

9fe779a2-7934-4037-81ea-22dacde3ab07

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO SOLUTIONS HOLDINGS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 262
2 A medical device with a moderate to high risk that requires special controls. 1530