POLYAXPOLYAXIAL SCREW, FT 815304065

GUDID 00887868041068

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: 00887868041068
• NIH Device Record Key: a7bfd735-8f8c-4393-81f6-89c9ba5c77bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYAXPOLYAXIAL SCREW, FT
• Version Model Number: 8153-04-065
• Catalog Number: 815304065
• 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	00887868041068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060969

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

Moist Heat or Steam Sterilization

[00887868041068]

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 [POLYAXPOLYAXIAL SCREW, FT]

• 00887868041914: 8153-55-100
• 00887868041907: 8153-55-095
• 00887868041891: 8153-55-090
• 00887868041884: 8153-55-085
• 00887868041877: 8153-55-080
• 00887868041860: 8153-55-075
• 00887868041853: 8153-55-070
• 00887868041846: 8153-55-065
• 00887868041839: 8153-55-060
• 00887868041822: 8153-55-055
• 00887868041815: 8153-55-050
• 00887868041785: 8153-55-045
• 00887868041754: 8153-55-040
• 00887868041723: 8153-55-035
• 00887868041693: 8153-55-030
• 00887868041662: 8153-55-025
• 00887868041136: 8153-04-100
• 00887868041129: 8153-04-095
• 00887868041112: 8153-04-090
• 00887868041105: 8153-04-085
• 00887868041099: 8153-04-080
• 00887868041082: 8153-04-075
• 00887868041075: 8153-04-070
• 00887868041068: 8153-04-065
• 00887868041051: 8153-04-060
• 00887868041044: 8153-04-055
• 00887868041037: 8153-04-050