360CAS

GUDID B432360CAS00100

Resection Guide Tool

KICO KNEE INNOVATION COMPANY PTY LIMITED

Robotic surgical navigation system application software
Primary Device IDB432360CAS00100
NIH Device Record Key4922e015-c004-440c-8d78-e6f0df7f0b15
Commercial Distribution StatusIn Commercial Distribution
Brand Name360CAS
Version Model NumberKIC-DND-0010
Company DUNS757918953
Company NameKICO KNEE INNOVATION COMPANY PTY LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB432360CAS00100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


[B432360CAS00100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-24
Device Publish Date2022-08-16

On-Brand Devices [360CAS]

B432360CAS2100360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigatio
B432360CAS01000ASM Cut Block
B432360CAS007604mm Hex Driver Long
B432360CAS00690Bone Fixator
B432360CAS00680CAS Flex Driver
B432360CAS00130CAS Pointer
B432360CAS00100Resection Guide Tool
B432360CAS00020Small CAS Tracker
B432360CAS01040ASM Horseshoe Fixation
B432360CAS00390Tracker Universal Grip
B432360CAS00030Large CAS Tracker
B432360CAS00240Pin Guide
B432360CASSET00050360CAS Accessories Set
B432360CASSET00110360CAS Accessories Set - Dual Camera
B432360CAS01250Fiducial Caddy
B432360CAS01230Fiducial Wrench
B432360CAS01200Resection Plane 90
B432360CAS01130Fiducial
B432360CAS01100Pointer
B432360CAS01090Array 075
B432360CAS01080Array 074
B432360CAS01070Array 072
B432360CAS01060UTC Click Stem
B432360CAS01050Universal Horseshoe Fixation
B432360CAS01030CAS General Instruments Tray
B432360CAS01020CAS Small Instruments Tray
B432360CAS00750CAS Sterrad Instruments Tray
B432360CAS00280UTC 2 Gimbal Stem
B432360CAS00260Gimbal Array Mount 90°
B432360CAS00250Gimbal Array Mount 0°
B432360CAS00040Male Bone Fixator
B432360CASSET00220360CAS Accessories Set - Dual Camera
B432360CAS01420Action Pointer
B432360CAS01260CAS Instruments Tray SET-0015
B432360CASSET00290360 CAS Accessories Set Nav Tower [100-115V]
B432360CASSET00280360 CAS Laptop Camera Set
B432360CASSET00230360 CAS Accessories Set Nav 2.0 [100-115V]
B432360CAS2200360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigatio
B432360CAS01470360CAS Enovis Single Knee Tray
B432360CAS01450Empowr Sizer UTC Adaptor
B432360CAS3100360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
B432360CAS02350Empowr 4-in-1 Drill Guide

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