PEG FULLY THREADED FP09

GUDID 00887868071461

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 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: 00887868071461
• NIH Device Record Key: ff30f579-e03f-436d-8d18-f7e8fa841555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEG FULLY THREADED
• Version Model Number: FP09
• Catalog Number: FP09
• 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
• 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
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• 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	00887868071461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081546

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

Moist Heat or Steam Sterilization

[00887868071461]

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 [PEG FULLY THREADED]

• 00887868071607: FP30
• 00887868071591: FP28
• 00887868071584: FP26
• 00887868071577: FP24
• 00887868071560: FP22
• 00887868071553: FP20
• 00887868071546: FP18
• 00887868071539: FP16
• 00887868071515: FP14
• 00887868071492: FP12
• 00887868071478: FP10
• 00887868071522: FP15
• 00887868071508: FP13
• 00887868071485: FP11
• 00887868071461: FP09
• 00887868071454: FP08