SIGNATURE Head - BIOLOX Delta

GUDID 03701089520799

AMPLITUDE SAS

Ceramic femoral head prosthesis

• Primary Device ID: 03701089520799
• NIH Device Record Key: f78d96b2-56dd-4374-a322-9f0795008507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE Head - BIOLOX Delta
• Version Model Number: 1-01-152-631
• Company DUNS: 634855407
• Company Name: AMPLITUDE SAS
• 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: true
• 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: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com
• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701089520799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2017-12-18

On-Brand Devices [SIGNATURE Head - BIOLOX Delta]

• 03701089520867: 1-01-152-644
• 03701089520850: 1-01-152-643
• 03701089520843: 1-01-152-642
• 03701089520836: 1-01-152-641
• 03701089520829: 1-01-152-634
• 03701089520812: 1-01-152-633
• 03701089520805: 1-01-152-632
• 03701089520799: 1-01-152-631
• 03701089520782: 1-01-152-624
• 03701089520775: 1-01-152-623
• 03701089520768: 1-01-152-622
• 03701089520751: 1-01-152-621
• 03701089520744: 1-01-152-613
• 03701089520737: 1-01-152-612
• 03701089520720: 1-01-152-611