5195-0-010

GUDID 07613327073713

Body Assembly Dynamic Joint Distractor II

Stryker Trauma SA

Cannulated surgical drill bit, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 07613327073713
• NIH Device Record Key: beaf9ea6-6835-4b5e-80ce-a1c4d0dc6b9a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5195-0-010
• Catalog Number: 5195-0-010
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327073713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002923

FDA Product Code

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

Sterilization

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

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-24

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• 07613327615203 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, R
• 07613327615234 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, std., L
• 07613327615425 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, L
• 07613327615517 - VARIAX: 2024-05-15 Volar DR Aiming Block, wide, L
• 07613327615579 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, narr., L
• 07613327615630 - VARIAX: 2024-05-15 Volar DR Aiming Block, narrow, L