234-010-079

GUDID 04546540754752

11MM X 35MM BIOABSORBABLE ACL SCREW

STRYKER CORPORATION

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 04546540754752
• NIH Device Record Key: d5d3a82a-5c2d-4f58-b257-4b0f310a7dc1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 234-010-079
• Catalog Number: 234-010-079
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
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• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540754752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993166

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-04

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