Crescendo Patella Component 32x8mm

GUDID 03701089524148

AMPLITUDE SAS

Polyethylene patella prosthesis

• Primary Device ID: 03701089524148
• NIH Device Record Key: 2803c5b5-d376-46df-b417-b22155cb183d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crescendo Patella Component 32x8mm
• Version Model Number: 1-01-07-7003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701089524148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

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: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2018-10-16

Devices Manufactured by AMPLITUDE SAS

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• 03701089514309 - VENTO Fixation Screw: 2024-02-19
• 03701089514316 - VENTO Fixation Screw: 2024-02-19
• 03701089514323 - VENTO Fixation Screw: 2024-02-19
• 03701089514330 - VENTO Fixation Screw: 2024-02-19
• 03701089514347 - VENTO Fixation Screw: 2024-02-19
• 03701089514354 - VENTO Fixation Screw: 2024-02-19
• 03701089514361 - VENTO Fixation Screw: 2024-02-19