AMPLITUDE 1-0210036

GUDID 03701089500838

Resurfacing Patellar Implant NM Cemented Ø 36 mm

AMPLITUDE SAS

Polyethylene patella prosthesis

• Primary Device ID: 03701089500838
• NIH Device Record Key: db14b235-33a9-4fe5-924e-4ac86d62f373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLITUDE
• Version Model Number: 1-0210036
• Catalog Number: 1-0210036
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701089500838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161414

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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: 2021-02-05
• Device Publish Date: 2017-08-08

On-Brand Devices [AMPLITUDE]

• 03701089500845: Resurfacing Patellar Implant NM Cemented Ø 39 mm
• 03701089500838: Resurfacing Patellar Implant NM Cemented Ø 36 mm
• 03701089500821: Resurfacing Patellar Implant NM Cemented Ø 33 mm
• 03701089500814: Resurfacing Patellar Implant NM Cemented Ø 30 mm