AFFIXUS®HIP FRACTURE NAIL LAG SCREW 814510080

GUDID 00887868038983

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868038983
• NIH Device Record Key: 4ee85a1a-8f3b-4af7-9e02-a3ad2c94d8ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFIXUS®HIP FRACTURE NAIL LAG SCREW
• Version Model Number: 8145-10-080
• Catalog Number: 814510080
• 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	00887868038983 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [AFFIXUS®HIP FRACTURE NAIL LAG SCREW]

• 00887868039089: 8145-10-130
• 00887868039072: 8145-10-125
• 00887868039065: 8145-10-120
• 00887868039058: 8145-10-115
• 00887868039041: 8145-10-110
• 00887868039034: 8145-10-105
• 00887868039027: 8145-10-100
• 00887868039010: 8145-10-095
• 00887868039003: 8145-10-090
• 00887868038990: 8145-10-085
• 00887868038983: 8145-10-080
• 00887868038976: 8145-10-075
• 00887868038969: 8145-10-070