OrthoGrid Hip

GUDID 00860003424803

OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement

Orthogrid Systems, Inc.

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• Primary Device ID: 00860003424803
• NIH Device Record Key: 8fadce9a-afbb-43d4-abee-1b454a8f0fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoGrid Hip
• Version Model Number: 1015-915-504
• 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	00860003424803 [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: 2021-03-15
• Device Publish Date: 2021-03-05

Devices Manufactured by Orthogrid Systems, Inc.

• 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: 2021-03-15OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
• 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.