STELLAR Knee 80-0002

GUDID 00850046497018

Kit, Total Knee, Right

POLARISAR, INC.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00850046497018
• NIH Device Record Key: a1ff71b0-2bac-4ffa-8ea5-c9fd9da96d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STELLAR Knee
• Version Model Number: Revision 03
• Catalog Number: 80-0002
• Company DUNS: 035071717
• Company Name: POLARISAR, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850046497018 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

[00850046497018]

Ethylene Oxide

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