AXS - BONE SCREWS, AXS, SELF-DRILLING - Stryker Leibinger GmbH & Co. KG

Duns Number:316153956

Device Description: BONE SCREWS, AXS, SELF-DRILLING

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More Product Details

Catalog Number

34-17905

Brand Name

AXS

Version/Model Number

34-17905

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

K172572,K172572

Product Code Details

Product Code

JEY

Product Code Name

PLATE, BONE

Device Record Status

Public Device Record Key

e70995f9-a073-4c42-93a4-8281ea9bb0ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER LEIBINGER GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 777
2 A medical device with a moderate to high risk that requires special controls. 2520