POLYAXLOCKING CORTICAL SCREW FULL THREAD 815045540

GUDID 00887868040894

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868040894
• NIH Device Record Key: 3078ee22-afa7-468c-b847-6fd353fa50ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYAXLOCKING CORTICAL SCREW FULL THREAD
• Version Model Number: 8150-45-540
• Catalog Number: 815045540
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868040894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003235

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

Moist Heat or Steam Sterilization

[00887868040894]

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: 2015-10-24

On-Brand Devices [POLYAXLOCKING CORTICAL SCREW FULL THREAD]

• 00887868041020: 8150-45-565
• 00887868041013: 8150-45-560
• 00887868040986: 8150-45-555
• 00887868040955: 8150-45-550
• 00887868040924: 8150-45-545
• 00887868040900: 8150-45-542
• 00887868040894: 8150-45-540
• 00887868040887: 8150-45-538
• 00887868040870: 8150-45-536
• 00887868040863: 8150-45-534
• 00887868040856: 8150-45-532
• 00887868040849: 8150-45-530
• 00887868040832: 8150-45-528
• 00887868040825: 8150-45-526
• 00887868040795: 8150-45-520
• 00887868040771: 8150-45-516
• 00887868040764: 8150-45-514