Affixus® Hip Fracture Nail 814609400

GUDID 00887868567155

Biomet Orthopedics, LLC

Femur nail

• Primary Device ID: 00887868567155
• NIH Device Record Key: 9a6a9420-809f-4000-953f-e97522603ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affixus® Hip Fracture Nail
• Version Model Number: 8146-09-400
• Catalog Number: 814609400
• 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

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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868567155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100238

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-06
• Device Publish Date: 2023-05-29

On-Brand Devices [Affixus® Hip Fracture Nail]

• 00887868567445: 8146-15-440
• 00887868567438: 8146-15-400
• 00887868567421: 8146-15-360
• 00887868567414: 8146-15-320
• 00887868567407: 8146-13-460
• 00887868567391: 8146-13-440
• 00887868567384: 8146-13-420
• 00887868567377: 8146-13-400
• 00887868567360: 8146-13-380
• 00887868567353: 8146-13-360
• 00887868567346: 8146-13-340
• 00887868567339: 8146-13-320
• 00887868567322: 8146-13-300
• 00887868567315: 8146-13-280
• 00887868567308: 8146-13-260
• 00887868567292: 8146-11-460
• 00887868567285: 8146-11-440
• 00887868567278: 8146-11-420
• 00887868567261: 8146-11-400
• 00887868567254: 8146-11-380
• 00887868567247: 8146-11-360
• 00887868567230: 8146-11-340
• 00887868567223: 8146-11-320
• 00887868567216: 8146-11-300
• 00887868567209: 8146-11-280
• 00887868567193: 8146-11-260
• 00887868567186: 8146-09-460
• 00887868567179: 8146-09-440
• 00887868567162: 8146-09-420
• 00887868567155: 8146-09-400
• 00887868567148: 8146-09-380
• 00887868567131: 8146-09-360
• 00887868567124: 8146-09-340
• 00887868567117: 8146-09-320
• 00887868567100: 8146-09-300
• 00887868567094: 8146-09-280
• 00887868567087: 8146-09-260
• 00887868566950: 8145-10-130
• 00887868566943: 8145-10-125
• 00887868566936: 8145-10-120
• 00887868566929: 8145-10-115
• 00887868566912: 8145-10-110
• 00887868566905: 8145-10-105
• 00887868566899: 8145-10-100
• 00887868566882: 8145-10-095
• 00887868566875: 8145-10-090
• 00887868566868: 8145-10-085
• 00887868566851: 8145-10-080
• 00887868566844: 8145-10-075
• 00887868566837: 8145-10-070