AXS, SmartLock 4727012E

GUDID 07613327385274

LOCKING SCREW,AXS,SELF-TAPPING

Stryker Leibinger GmbH & Co. KG

Sternal fixation device

• Primary Device ID: 07613327385274
• NIH Device Record Key: 7bed758f-1a4b-4365-ba11-5b0769fd3d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXS, SmartLock
• Version Model Number: 4727012E
• Catalog Number: 4727012E
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327385274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183172

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[07613327385274]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

On-Brand Devices [AXS, SmartLock]

• 07613327402049: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327401943: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327401882: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327401752: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327401691: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327401684: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327385274: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327385229: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327385212: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327385182: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327385168: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327384994: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327384956: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327384925: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327384901: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327384840: LOCKING SCREW,AXS,SELF-DRILLING
• 07613327384642: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327384604: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327384574: LOCKING SCREW,AXS,SELF-TAPPING
• 07613327384543: LOCKING SCREW,AXS,SELF-DRILLING
• 37613327384674: LOCKING SCREW,AXS,SELF-DRILLING