FRS™ SCREW P2022

GUDID 08426750013862

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08426750013862
• NIH Device Record Key: 4b7f19cd-4b65-4493-88fe-0625b0fd3e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRS™ SCREW
• Version Model Number: P2022
• Catalog Number: P2022
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426750013862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962236

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[08426750013862]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2015-10-24

On-Brand Devices [FRS™ SCREW]

• 00887868115752: P2016
• 00887868115745: P2014
• 00887868115738: P2012
• 00887868115721: P2010
• 00887868115677: P1034
• 00887868115660: P1032
• 00887868115653: P1030
• 00887868115646: P1028
• 00887868115639: P1026
• 00887868115622: P1024
• 08426750013886: P2026
• 08426750013879: P2024
• 08426750013862: P2022
• 08426750013855: P2020
• 08426750013848: P2018