Kinos Aeros Instrumentation

GUDID 00840097515441

Pilot Driven Gear

Restor3d, Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00840097515441
• NIH Device Record Key: 4f1a0855-906d-4a95-a845-39702883d442
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Aeros Instrumentation
• Version Model Number: 5871-4102
• Company DUNS: 080819836
• Company Name: Restor3d, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097515441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242868

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

[00840097515441]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-09
• Device Publish Date: 2025-05-01

On-Brand Devices [Kinos Aeros Instrumentation]

• 00840097516325: Pilot Drill Wrench
• 00840097516318: Reamer Head Loader
• 00840097516301: Heel Impactor
• 00840097516295: Heel Targeting Guide
• 00840097516134: Threaded Heel Rod
• 00840097516127: Pilot Heel Drill
• 00840097516110: Kinos Modular Stem Tray – K-Wire Tube
• 00840097516103: Kinos Modular Stem Tray – Full Assembly
• 00840097516097: Reamer Guide
• 00840097515441: Pilot Driven Gear
• 00840097515335: Kinos Modular Stem Tray – Talar Prep Caddy Lid
• 00840097515328: Kinos Modular Stem Tray – Talar Prep Caddy
• 00840097515311: Kinos Modular Stem Tray – Pilot Drill Caddy Lid
• 00840097515304: Kinos Modular Stem Tray – Pilot Drill Caddy
• 00840097515298: Kinos Modular Stem Tray – Lid
• 00840097515281: Kinos Modular Stem Tray – Level 2
• 00840097515274: Kinos Modular Stem Tray – Level 1
• 00840097515267: Kinos Modular Stem Tray – Base Tray
• 00840097515250: Kinos Tibial Trial Screw, 8-32
• 00840097515052: Reamer Lock Plate
• 00840097515045: 18mm Pilot Drill Bit
• 00840097515038: 16mm Pilot Drill Bit
• 00840097515021: Pilot Driving Shaft
• 00840097515007: Pilot Drill Guide
• 00840097514994: Pilot Drill Housing
• 00840097514987: AP Rail Drill Bit
• 00840097514970: AP Rail Drill Guide
• 00840097514963: Stem Inserter
• 00840097514956: Stem Impactor