MySpine Webplanner & MyBalance

GUDID 07630345725905

WebPlanner Spine Software

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

• Primary Device ID: 07630345725905
• NIH Device Record Key: e6f65f89-7467-43b2-a187-7010ce8c0c40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MySpine Webplanner & MyBalance
• Version Model Number: 98.46.WEBPSPINE
• 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	07630345725905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211386

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: 2021-08-04
• Device Publish Date: 2021-07-27

On-Brand Devices [MySpine Webplanner & MyBalance]

• 07630345725905: WebPlanner Spine Software
• 07630345725899: MyPlanner Spine