TENXOR 4936-0-015

GUDID 07613327088755

Open Ring

Stryker Trauma SA

External orthopaedic fixation system, reusable

• Primary Device ID: 07613327088755
• NIH Device Record Key: 56c9704b-f868-4b0e-ad1a-78a9c5e30a7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENXOR
• Version Model Number: 4936-0-015
• Catalog Number: 4936-0-015
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	07613327088755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000957

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[07613327088755]

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: 2016-09-24

On-Brand Devices [TENXOR]

• 07613327095210: Wire Post
• 07613327095203: Wire Post - Short
• 07613327091489: Ring To Tube Clamp (red)
• 07613327091472: Ring To Tube Clamp (blue)
• 07613327091458: Ring Clamp
• 07613327089134: Pin Post
• 07613327088786: Open Ring
• 07613327088779: Open Ring
• 07613327088755: Open Ring
• 04546540701831: Foot Ring
• 04546540701824: Foot Ring
• 04546540701817: Foot Ring
• 07613327095227: Wire Tensioner