360CAS

GUDID B432360CAS2200

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.

KICO KNEE INNOVATION COMPANY PTY LIMITED

Robotic surgical navigation system application software

• Primary Device ID: B432360CAS2200
• NIH Device Record Key: 4d36a272-b9ce-430e-9201-9381df849afc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 360CAS
• Version Model Number: 2.2.0
• Company DUNS: 757918953
• Company Name: KICO KNEE INNOVATION COMPANY PTY LIMITED
• 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
HIBCC	B432360CAS2200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223927

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: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [360CAS]

• B432360CAS2100: 360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigatio
• B432360CAS01000: ASM Cut Block
• B432360CAS00760: 4mm Hex Driver Long
• B432360CAS00690: Bone Fixator
• B432360CAS00680: CAS Flex Driver
• B432360CAS00130: CAS Pointer
• B432360CAS00100: Resection Guide Tool
• B432360CAS00020: Small CAS Tracker
• B432360CAS01040: ASM Horseshoe Fixation
• B432360CAS00390: Tracker Universal Grip
• B432360CAS00030: Large CAS Tracker
• B432360CAS00240: Pin Guide
• B432360CASSET00050: 360CAS Accessories Set
• B432360CASSET00110: 360CAS Accessories Set - Dual Camera
• B432360CAS01250: Fiducial Caddy
• B432360CAS01230: Fiducial Wrench
• B432360CAS01200: Resection Plane 90
• B432360CAS01130: Fiducial
• B432360CAS01100: Pointer
• B432360CAS01090: Array 075
• B432360CAS01080: Array 074
• B432360CAS01070: Array 072
• B432360CAS01060: UTC Click Stem
• B432360CAS01050: Universal Horseshoe Fixation
• B432360CAS01030: CAS General Instruments Tray
• B432360CAS01020: CAS Small Instruments Tray
• B432360CAS00750: CAS Sterrad Instruments Tray
• B432360CAS00280: UTC 2 Gimbal Stem
• B432360CAS00260: Gimbal Array Mount 90°
• B432360CAS00250: Gimbal Array Mount 0°
• B432360CAS00040: Male Bone Fixator
• B432360CASSET00220: 360CAS Accessories Set - Dual Camera
• B432360CAS01420: Action Pointer
• B432360CAS01260: CAS Instruments Tray SET-0015
• B432360CASSET00290: 360 CAS Accessories Set Nav Tower [100-115V]
• B432360CASSET00280: 360 CAS Laptop Camera Set
• B432360CASSET00230: 360 CAS Accessories Set Nav 2.0 [100-115V]
• B432360CAS2200: 360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigatio
• B432360CAS01470: 360CAS Enovis Single Knee Tray
• B432360CAS01450: Empowr Sizer UTC Adaptor
• B432360CAS3100: 360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
• B432360CAS02350: Empowr 4-in-1 Drill Guide
• B432360CAS3110: 360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3