STELLAR Knee 80-0004-STREAM

GUDID 00850046497124

Kit, Streaming Head Mounted Device

POLARISAR, INC.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00850046497124
• NIH Device Record Key: 9c32f8ac-f253-4a9e-9a19-fc33f314341e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STELLAR Knee
• Version Model Number: Revision 00
• Catalog Number: 80-0004-STREAM
• Company DUNS: 035071717
• Company Name: POLARISAR, 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850046497124 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [STELLAR Knee]

• 00850046497162: Kit, Observer Head Mounted Device, V2
• 00850046497155: Kit, Streaming Head Mounted Device, V2
• 00850046497148: Kit, Head Mounted Device, V2
• 00850046497131: STELLAR Knee Application, V2
• 00850046497124: Kit, Streaming Head Mounted Device
• 00850046497117: Kit, Head Mounted Device
• 00850046497100: STELLAR Knee Application
• 00850046497087: HAND DRIVER
• 00850046497070: HUDSON ADAPTER
• 00850046497063: PROXIMAL TIBIA RESECTION BLOCK - RIGHT
• 00850046497056: PROXIMAL TIBIA RESECTION BLOCK - LEFT
• 00850046497049: DISTAL FEMUR RESECTION BLOCK
• 00850046497032: Universal Resection Guide
• 00850046497025: STELLAR Knee Reusable Instrumentation
• 00850046497018: Kit, Total Knee, Right
• 00850046497001: Kit, Total Knee, Left