MOTO Patella

GUDID 07630971262485

MOTO PATELLA D35

Medacta International SA

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