BONE SCREW, CORTICAL 805035020

GUDID 00887868033490

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868033490
• NIH Device Record Key: 1d7d520e-6940-4436-9d93-32526d106154
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONE SCREW, CORTICAL
• Version Model Number: 8050-35-020
• Catalog Number: 805035020
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868033490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905048

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

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 [BONE SCREW, CORTICAL]

• 00887868004803: 1515-90
• 00887868004797: 1515-85
• 00887868033902: 8050-55-035
• 00887868033896: 8050-55-030
• 00887868033889: 8050-55-025
• 00887868077197: 14022-30
• 00887868034077: 8050-55-120
• 00887868034060: 8050-55-115
• 00887868034053: 8050-55-110
• 00887868034046: 8050-55-105
• 00887868034039: 8050-55-100
• 00887868034022: 8050-55-095
• 00887868034015: 8050-55-090
• 00887868034008: 8050-55-085
• 00887868009877: 1515-120
• 00887868009860: 1515-115
• 00887868009853: 1515-110
• 00887868009846: 1515-105
• 00887868009839: 1515-100
• 00887868006326: 14022-95
• 00887868006319: 14022-90
• 00887868006302: 14022-85
• 00887868006296: 14022-80
• 00887868006289: 14022-75
• 00887868006272: 14022-70
• 00887868006265: 14022-65
• 00887868006258: 14022-60
• 00887868006241: 14022-58
• 00887868006234: 14022-56
• 00887868006227: 14022-54
• 00887868006210: 14022-52
• 00887868006203: 14022-50
• 00887868006197: 14022-48
• 00887868006180: 14022-46
• 00887868006173: 14022-44
• 00887868006166: 14022-42
• 00887868006159: 14022-40
• 00887868006142: 14022-38
• 00887868006135: 14022-36
• 00887868006128: 14022-34
• 00887868006111: 14022-32
• 00887868006098: 14022-28
• 00887868006081: 14022-26
• 00887868004810: 1515-95
• 00887868010415: 14377-120
• 00887868010408: 14377-115
• 00887868010392: 14377-110
• 00887868010385: 14377-105
• 00887868010378: 14377-100
• 00887868009990: 14022-100