AXS 56-14009E

GUDID 07613327358919

BONE SCREW,EMERG.,AXS,SELF-TAP.

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 07613327358919
• NIH Device Record Key: c1cc9081-24be-436c-991e-7f556ab75c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXS
• Version Model Number: 56-14009E
• Catalog Number: 56-14009E
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0
• Length: 9 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327358919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172572

FDA Product Code

• JEY: PLATE, BONE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

[07613327358919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-18

On-Brand Devices [AXS]

• 07613327376364: BONE SCREW, AXS, SELF-DRILLING
• 07613327376357: BONE SCREW, AXS, SELF-TAPPING
• 07613327369472: AXS SCREWDRIVER BLADE 1.2/1.7MM
• 07613327369465: AXS SCREWDRIVER BLADE 1.2/1.7MM
• 07613327369458: AXS SCREWDRIVER BLADE 1.2/1.7MM
• 07613327359411: BONE SCREW, AXS, SELF-DRILLING
• 07613327359381: BONE SCREW, AXS, SELF-TAPPING
• 07613327359374: BONE SCREW, AXS, SELF-DRILLING
• 07613327359343: BONE SCREW, AXS, SELF-DRILLING
• 07613327359312: BONE SCREW, AXS, SELF-DRILLING
• 07613327359268: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327359251: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327359220: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327359206: BONE SCREW, AXS, SELF-TAPPING
• 07613327359183: BONE SCREW, AXS, SELF-TAPPING
• 07613327359121: BONE SCREW, AXS, SELF-TAPPING
• 07613327359091: BONE SCREW, AXS, SELF-DRILLING
• 07613327359084: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327359077: BONE SCREW, AXS, SELF-DRILLING
• 07613327359039: BONE SCREW, AXS, SELF-TAPPING
• 07613327359022: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327359015: BONE SCREW, AXS, SELF-TAPPING
• 07613327358995: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358971: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327358964: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327358957: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358933: BONE SCREW, AXS, SELF-DRILLING
• 07613327358926: BONE SCREW, AXS, SELF-TAPPING
• 07613327358919: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358896: BONE SCREW, AXS, SELF-TAPPING
• 07613327358889: BONE SCREW, AXS, SELF-TAPPING
• 07613327358872: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358865: BONE SCREW, AXS, SELF-TAPPING
• 07613327358858: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358841: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327358834: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358827: BONE SCREW, AXS, SELF-TAPPING
• 07613327358810: BONE SCREW, AXS, SELF-DRILLING
• 07613327358797: BONE SCREW, AXS, SELF-TAPPING
• 07613327358773: BONE SCREW, AXS, SELF-TAPPING
• 07613327358742: BONE SCREW, AXS, SELF-TAPPING
• 07613327358704: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358698: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358681: BONE SCREW, AXS, SELF-TAPPING
• 07613327358674: BONE SCREW, AXS, SELF-TAPPING
• 07613327358650: BONE SCREW, AXS, SELF-TAPPING
• 07613327358636: BONE SCREW,EMERG.,AXS,SELF-TAP.
• 07613327358612: BONE SCREW, AXS, SELF-TAPPING
• 07613327358605: BONE SCREW, AXS, SELF-TAPPING
• 07613327358599: BONE SCREW, AXS, SELF-DRILLING