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510(k) Data Aggregation
K Number
K201229Device Name
Intai Anatomic Locking Plate and Screw System
Manufacturer
Intai Technology Corporation
Date Cleared
2022-03-11
(673 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Intai Technology Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intai Anatomy Locking Plate and Screw System is provided non-sterile. The system is intended for use in fixation of fractures to the various bones, including; clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults. This system is not indicated for use in the spine.
Device Description
The Intai Anatomical Locking Plate and Screw System offers anatomically contoured plates for use with non-locking and locking screws. The plates are provided with locking holes as well as holes for cortex screws to enhance compression pressure. With the combination of locking and compression technology, the system further ensures the stability of the implant devices.
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K Number
K180523Device Name
INTAI Surgery Navigation System
Manufacturer
Intai Technology Corporation
Date Cleared
2019-09-20
(570 days)
Product Code
OLO, HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Intai Technology Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.
Example procedures include but are not limited to:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Device Description
The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation.
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