MOTO Patella

GUDID 07630971262485

MOTO PATELLA D35

Medacta International SA

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 07630971262485
• NIH Device Record Key: b59bbde1-6c35-40b2-8d83-72e22a19c6b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOTO Patella
• Version Model Number: 02.15.0035
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630971262485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200122

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

On-Brand Devices [MOTO Patella]

• 07630971262508: MOTO PATELLA D41
• 07630971262492: MOTO PATELLA D38
• 07630971262485: MOTO PATELLA D35
• 07630971262478: MOTO PATELLA D32
• 07630971262461: MOTO PATELLA D29
• 07630971262454: MOTO PATELLA D26