92-53228

GUDID 07613154629602

LOW PROFILE 3-D BOX PLATE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07613154629602
• NIH Device Record Key: 05838348-0f4b-4bd3-b02a-9d83f71d8c3e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-53228
• Catalog Number: 92-53228
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154629602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031659

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

Moist Heat or Steam Sterilization

[07613154629602]

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: 2015-09-24

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327634945 - NA: 2024-10-01 Drill for 4/5mm screws SYK
• 07613327547429 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547436 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547443 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547450 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547467 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547474 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327616118 - N/A: 2024-08-30 Spine Guidance 5 Software