TWISTOFF ®TWISTOFF SCREW P2811

GUDID 00887868116148

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868116148
• NIH Device Record Key: 85cbf34a-471f-4b74-b016-b86a5948d364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWISTOFF ®TWISTOFF SCREW
• Version Model Number: P2811
• Catalog Number: P2811
• 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
• 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	00887868116148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962233

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868116148]

Moist Heat or Steam Sterilization

[00887868116148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [TWISTOFF ®TWISTOFF SCREW]

• 00887868116179: P2814
• 00887868116162: P2813
• 00887868116155: P2812
• 00887868116148: P2811