MyPAO Planning report

GUDID 07630971243378

MyPAO Planning report

Medacta International SA

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software 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

• 07630345789372 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø10x90 STD Full thread
• 07630345789389 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø10x100 STD Full thread
• 07630345789396 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø10x110 STD Full thread
• 07630345789402 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø10x120 STD Full thread
• 07630345789419 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø7x65 STD Partial thread
• 07630345789426 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø7x70 STD Partial thread
• 07630345789433 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø7x80 STD Partial thread
• 07630345789440 - M.U.S.T. Pedicle Screw System: 2024-04-24 MUST S2AI all Ti Screw Ø7x80 STD Partial thread