Right Femur - Left Tibia Arm Assembly 50-0014

GUDID 00850046497193

For Use with 80-0006.

POLARISAR, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850046497193
• NIH Device Record Key: e82da0d2-7413-4f30-b34d-29b3af72a7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Right Femur - Left Tibia Arm Assembly
• Version Model Number: 50-0014
• Catalog Number: 50-0014
• 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: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com
• Phone: 800-903-6894
• Email: customerservice@thinkpolaris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850046497193 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

[00850046497193]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by POLARISAR, INC.

• 00850046497179 - STELLAR Knee Marker Kit: 2025-06-24 For use with TruFix Pin Kit (80-0005)
• 00850046497186 - TruFix Pin Kit: 2025-06-24 TruFix Pin Kit for use with 80-0006 STELLAR Knee Marker Kit
• 00850046497193 - Right Femur - Left Tibia Arm Assembly: 2025-06-24For Use with 80-0006.
• 00850046497193 - Right Femur - Left Tibia Arm Assembly: 2025-06-24 For Use with 80-0006.
• 00850046497209 - Left Femur - Right Tibia Arm Assembly: 2025-06-24 For Use with 80-0006.
• 00850046497001 - STELLAR Knee: 2025-03-11 Kit, Total Knee, Left
• 00850046497018 - STELLAR Knee: 2025-03-11 Kit, Total Knee, Right
• 00850046497025 - STELLAR Knee: 2025-03-11 STELLAR Knee Reusable Instrumentation
• 00850046497032 - STELLAR Knee: 2025-03-11 Universal Resection Guide