VARIAX - Locking Screw, T6 - Stryker Trauma SA

Duns Number:481999654

Device Description: Locking Screw, T6

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

663726

Brand Name

VARIAX

Version/Model Number

663726

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K180500

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

20c247db-4a95-4cab-b739-a13b66b0ed2f

Public Version Date

April 25, 2022

Public Version Number

2

DI Record Publish Date

June 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER TRAUMA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2606
2 A medical device with a moderate to high risk that requires special controls. 9953
3 A medical device with high risk that requires premarket approval 186