XIA STAINLESS STEEL - MONOAXIAL SCREW - Stryker Corporation

Duns Number:149183167

Device Description: MONOAXIAL SCREW

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


More Product Details

Catalog Number

48220630

Brand Name

XIA STAINLESS STEEL

Version/Model Number

48220630

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

-

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

eb940e7e-0dd0-4c30-8f85-2b828e3b6730

Public Version Date

February 25, 2022

Public Version Number

5

DI Record Publish Date

December 08, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86