SIGNATURE Head - BIOLOX Delta

GUDID 03701089520843

AMPLITUDE SAS

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 03701089520843
• NIH Device Record Key: d4579bea-0511-434a-a9aa-862f3fa61826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE Head - BIOLOX Delta
• Version Model Number: 1-01-152-642
• 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	03701089520843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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