OrthoGrid Hip AI

Basic Information

• Brand Name: OrthoGrid Hip AI
• Primary DI: 00860003424834
• Version / Model: 1015-915-505
• Company Name: Orthogrid Systems, Inc.
• Labeler DUNS: 079674160
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 1
• Public Version Date: 2022-05-27
• Public Version Status: New
• Public Device Record Key: 729a6855-2622-47c1-b724-a863a2a87f25

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64050	Orthopaedic fluoroscopic grid software	A software program intended for use during an orthopaedic surgical procedure to enhance fluoroscopic images with a visual tool in the form of an overlaid grid, whereby the grid is intended to highlight fluoroscopic distortion and e.g., assist placement of an implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003424834	GS1

Premarket Submissions

Submission Number	Supplement Number
K210136	000