SOLID CANCELLOUS SCREW 815761105

GUDID 00887868042805

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868042805
• NIH Device Record Key: 77d5b2a2-a8ee-4bf3-9f3e-4f9af820d4c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLID CANCELLOUS SCREW
• Version Model Number: 8157-61-105
• Catalog Number: 815761105
• 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	00887868042805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

Moist Heat or Steam Sterilization

[00887868042805]

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 [SOLID CANCELLOUS SCREW]

• 00887868010460: 14520-120
• 00887868010453: 14520-115
• 00887868010446: 14520-110
• 00887868010439: 14520-105
• 00887868010422: 14520-100
• 00887868009525: 14520-95
• 00887868009518: 14520-90
• 00887868009501: 14520-85
• 00887868009495: 14520-80
• 00887868009488: 14520-75
• 00887868009471: 14520-70
• 00887868009464: 14520-65
• 00887868009457: 14520-60
• 00887868009440: 14520-55
• 00887868009433: 14520-50
• 00887868009426: 14520-45
• 00887868009419: 14520-40
• 00887868009402: 14520-35
• 00887868009396: 14520-30
• 00887868009389: 14520-25
• 00887868007316: 14224-80
• 00887868007309: 14224-75
• 00887868007293: 14224-70
• 00887868007286: 14224-65
• 00887868007279: 14224-60
• 00887868007262: 14224-58
• 00887868007255: 14224-56
• 00887868007248: 14224-54
• 00887868007231: 14224-52
• 00887868007224: 14224-50
• 00887868007217: 14224-48
• 00887868007200: 14224-46
• 00887868007194: 14224-44
• 00887868007187: 14224-42
• 00887868007170: 14224-40
• 00887868007163: 14224-38
• 00887868007156: 14224-36
• 00887868007149: 14224-34
• 00887868007132: 14224-32
• 00887868007125: 14224-30
• 00887868007118: 14224-28
• 00887868007101: 14224-26
• 00887868007095: 14224-24
• 00887868007088: 14224-22
• 00887868007071: 14224-20
• 00887868042812: 8157-61-110
• 00887868042805: 8157-61-105
• 00887868042799: 8157-61-100
• 00887868042782: 8157-61-095
• 00887868042775: 8157-61-090