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510(k) Data Aggregation
K Number
K223558Device Name
CUVIS-spine
Manufacturer
Date Cleared
2023-06-22
(206 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Curexo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spationing and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
Device Description
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments.
CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Drape, Marker Ball, Patient Marker, Clamp, Adapter, Pin, Pin vise, Slide Hammer, Marker Driver, Detector calibrator, Dilator, Serration-tip dilator, Bur, Awl, Probe, Lenke probe, Tapper, Stylet tapper, Screwdriver, Instrument container.
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K Number
K222698Device Name
CUVIS-spine
Manufacturer
Date Cleared
2022-10-07
(30 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Curexo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous surgical procedures provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
Device Description
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments. CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container.
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K Number
K201569Device Name
CUVIS-spine
Manufacturer
Date Cleared
2021-05-19
(342 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Curexo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
Device Description
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments.
The CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container.
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