POLYAXNONLOCKING SCREW, PT 815455085

GUDID 00887868042010

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: 00887868042010
• NIH Device Record Key: 182844c0-a458-403e-adfc-2b8f333062dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYAXNONLOCKING SCREW, PT
• Version Model Number: 8154-55-085
• Catalog Number: 815455085
• 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	00887868042010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003235

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

Moist Heat or Steam Sterilization

[00887868042010]

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 [POLYAXNONLOCKING SCREW, PT]

• 00887868042041: 8154-55-100
• 00887868042034: 8154-55-095
• 00887868042027: 8154-55-090
• 00887868042010: 8154-55-085
• 00887868042003: 8154-55-080
• 00887868041990: 8154-55-075
• 00887868041983: 8154-55-070
• 00887868041976: 8154-55-065
• 00887868041969: 8154-55-060
• 00887868041952: 8154-55-055
• 00887868041945: 8154-55-050
• 00887868041938: 8154-55-045
• 00887868041921: 8154-55-040