MyPAO

GUDID 07630542724442

MyPAO PreOp Guide SA Right

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630542724442
• NIH Device Record Key: 68b7a6bc-3bcd-4529-920f-0f0bba4ab7f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyPAO
• Version Model Number: 12.1042
• 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	07630542724442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242603

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

[07630542724442]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [MyPAO]

• 07630971287624: MyPAO Real-Sys Bone Model Pre-Op Left
• 07630971287617: MyPAO Real-Sys Bone Model Pre-Op Right
• 07630971287600: MyPAO Realignment system Bone Model Left
• 07630971287594: MyPAO Realignment system Bone Model Right
• 07630971287587: MyPAO PreOp drill guide Left
• 07630971287570: MyPAO PreOp drill guide Right
• 07630971287563: MyPAO Realignment Arc Left
• 07630971287556: MyPAO Realignment Arc Right
• 07630971287549: MyPAO acetabulum rep guide Left
• 07630971287532: MyPAO acetabulum rep guide Right
• 07630971287525: MyPAO ilium rep guide Left
• 07630971287518: MyPAO ilium rep guide Right
• 07630971292178: MyPAO Realignment System Set - Tray single level
• 07630971281899: MyPAO Locking key
• 07630971281882: MyPAO pin inserter
• 07630971281875: MyPAO T-Handle
• 07630971281868: MyPAO Threaded pin Ø5
• 07630971281851: MyPAO Threaded pin Ø4
• 07630971281844: MyPAO Ilium metal connector
• 07630971292536: MyPAO SWO - Bone Model PostOp Left
• 07630971292529: MyPAO SWO - Bone Model PostOp Right
• 07630542724497: MyPAO Real-Sys Bone Model SA Pre-Op Left
• 07630542724480: MyPAO Real-Sys Bone Model SA Pre-Op Right
• 07630542724473: MyPAO Real-Sys Bone Model SA Post-Op Left
• 07630542724466: MyPAO Real-Sys Bone Model SA Post-Op Right
• 07630542724459: MyPAO PreOp Guide SA Left
• 07630542724442: MyPAO PreOp Guide SA Right
• 07630542724435: MyPAO Realignment Guide SA Left
• 07630542724428: MyPAO Realignment Guide SA Right