POLYAXCANNULATED LOCKING SCREW, FT 815308065

GUDID 00887868041198

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: 00887868041198
• NIH Device Record Key: c8aa6b8f-82b6-4368-8b90-957550a6185e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYAXCANNULATED LOCKING SCREW, FT
• Version Model Number: 8153-08-065
• Catalog Number: 815308065
• 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	00887868041198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060969

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

Moist Heat or Steam Sterilization

[00887868041198]

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 [POLYAXCANNULATED LOCKING SCREW, FT]

• 00887868041242: 8153-08-090
• 00887868041235: 8153-08-085
• 00887868041228: 8153-08-080
• 00887868041211: 8153-08-075
• 00887868041204: 8153-08-070
• 00887868041198: 8153-08-065
• 00887868041181: 8153-08-060
• 00887868041174: 8153-08-055
• 00887868041167: 8153-08-050
• 00887868041150: 8153-08-035
• 00887868041143: 8153-08-025