SIGNATURE Head - CoCr

GUDID 03701089520638

AMPLITUDE SAS

Metallic femoral head prosthesis

• Primary Device ID: 03701089520638
• NIH Device Record Key: 8b143618-19a7-4f61-8869-48177bcdd654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE Head - CoCr
• Version Model Number: 1-01-152-024
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701089520638 [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: 2020-04-06
• Device Publish Date: 2017-12-18

On-Brand Devices [SIGNATURE Head - CoCr]

• 03701089520713: 1-01-152-044
• 03701089520706: 1-01-152-043
• 03701089520690: 1-01-152-042
• 03701089520683: 1-01-152-041
• 03701089520676: 1-01-152-034
• 03701089520669: 1-01-152-033
• 03701089520652: 1-01-152-032
• 03701089520645: 1-01-152-031
• 03701089520638: 1-01-152-024
• 03701089520621: 1-01-152-023
• 03701089520614: 1-01-152-022
• 03701089520607: 1-01-152-021
• 03701089520591: 1-01-151-013
• 03701089520584: 1-01-151-012
• 03701089520577: 1-01-151-011