FULLY THREADED CANCELLOUS SCREW 855340034

GUDID 00887868059056

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868059056
• NIH Device Record Key: 0c549d84-0682-4e45-9477-a8fe15083b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FULLY THREADED CANCELLOUS SCREW
• Version Model Number: 8553-40-034
• Catalog Number: 855340034
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868059056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• HTN: WASHER, BOLT NUT

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 [FULLY THREADED CANCELLOUS SCREW]

• 00887868060359: 8557-61-110
• 00887868060342: 8557-61-105
• 00887868060335: 8557-61-100
• 00887868060328: 8557-61-095
• 00887868060311: 8557-61-090
• 00887868060304: 8557-61-085
• 00887868060298: 8557-61-080
• 00887868060281: 8557-61-075
• 00887868060274: 8557-61-070
• 00887868060267: 8557-61-065
• 00887868060250: 8557-61-060
• 00887868060243: 8557-61-055
• 00887868060236: 8557-61-050
• 00887868060229: 8557-61-045
• 00887868060212: 8557-61-040
• 00887868060205: 8557-61-035
• 00887868060199: 8557-61-030
• 00887868060182: 8557-61-025
• 00887868059179: 8553-40-070
• 00887868059162: 8553-40-065
• 00887868059155: 8553-40-060
• 00887868059148: 8553-40-055
• 00887868059131: 8553-40-050
• 00887868059124: 8553-40-048
• 00887868059117: 8553-40-046
• 00887868059100: 8553-40-044
• 00887868059094: 8553-40-042
• 00887868059087: 8553-40-040
• 00887868059070: 8553-40-038
• 00887868059063: 8553-40-036
• 00887868059056: 8553-40-034
• 00887868059049: 8553-40-032
• 00887868059032: 8553-40-030
• 00887868059025: 8553-40-028
• 00887868059018: 8553-40-026
• 00887868059001: 8553-40-024
• 00887868058998: 8553-40-022
• 00887868058981: 8553-40-020
• 00887868058974: 8553-40-018
• 00887868058967: 8553-40-016
• 00887868058950: 8553-40-014
• 00887868058943: 8553-40-012
• 00887868058936: 8553-40-010
• 00887868448058: 8557-61-095
• 00887868448041: 8557-61-090
• 00887868448034: 8557-61-085
• 00887868448027: 8557-61-080
• 00887868448010: 8557-61-075
• 00887868448003: 8557-61-070
• 00887868447990: 8557-61-065