OrthoGrid Hip AI

GUDID 00860003424834

OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement

Orthogrid Systems, Inc.

Orthopaedic fluoroscopic grid software Orthopaedic fluoroscopic grid software Orthopaedic fluoroscopic grid software Orthopaedic fluoroscopic grid software Orthopaedic fluoroscopic grid software Orthopaedic fluoroscopic grid software

• Primary Device ID: 00860003424834
• NIH Device Record Key: 729a6855-2622-47c1-b724-a863a2a87f25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoGrid Hip AI
• Version Model Number: 1015-915-505
• Company DUNS: 079674160
• Company Name: Orthogrid Systems, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00860003424834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210136

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: 2022-05-27
• Device Publish Date: 2022-05-19

Devices Manufactured by Orthogrid Systems, Inc.

• 00860003424834 - OrthoGrid Hip AI: 2022-05-27OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
• 00860003424834 - OrthoGrid Hip AI: 2022-05-27 OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
• 00860003424827 - OrthoGrid Hip Trauma: 2021-09-06 OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures
• 00860003424803 - OrthoGrid Hip: 2021-03-15 OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
• 00860003424810 - OrthoGrid Hip Preservation: 2021-03-15 OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image analysis tools for Hip Preservation.