MyPAO Planning report

GUDID 07630971243378

MyPAO Planning report

Medacta International SA

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 07630971243378
• NIH Device Record Key: 65c7d536-cbab-4cce-bbc3-7556c33722ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyPAO Planning report
• Version Model Number: 05.07.001SWO
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	07630971243378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200589

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-02
• Device Publish Date: 2021-02-22

Devices Manufactured by Medacta International SA

• 07630345726896 - Surgical Manual Instrument: 2025-11-25 GRS line-to-line central peg reamer L20
• 07630542750373 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø32/+3
• 07630542750380 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø32/+6
• 07630542750397 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø36/+0
• 07630542750403 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø36/+3
• 07630542750410 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø36/+6
• 07630542750427 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø39/+0
• 07630542750434 - MSS - Humeral reverse liners: 2025-11-25 Hum. rev. constrained HCPE liner Ø39/+3