FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system
[REGULATORY ACTION]Aug 23, 2022 · Point Robotics MedTech · POINT Kinguide Robotic-Assisted Surgical System · United States (multiple hotel chains)
Failure Mode
REGULATORY ACTION
Event Date
Aug 23, 2022
Primary Entity
Point Robotics MedTech
Robotic Platform
POINT Kinguide Robotic-Assisted Surgical System
Jurisdiction / Location
United States (multiple hotel chains)
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Point Robotics MedTech received FDA 510(k) clearance for its POINT Kinguide Robotic-Assisted Surgical System, the first hand-held spinal surgical robot from Taiwan. The system is cleared for minimally invasive spine surgery procedures.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.prnewswire.com/news-releases/first-ever-spinal-surgical-hand-held-robot-by-point-robotics-medtech-to-make-its-worldwide-debut-in-the-united-states-301635498.html
https://www.prnewswire.com/news-releases/first-ever-spinal-surgical-hand-held-robot-by-point-robotics-medtech-to-make-its-worldwide-debut-in-the-united-states-301635498.html
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Details
Incident Context & FAQ
What happened in FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
Point Robotics MedTech received FDA 510(k) clearance for its POINT Kinguide Robotic-Assisted Surgical System, the first hand-held spinal surgical robot from Taiwan. The system is cleared for minimally invasive spine surgery procedures.
When did this incident occur?
The incident is recorded as occurring on August 23, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
POINT Kinguide Robotic-Assisted Surgical System by Point Robotics MedTech is the recorded robot involved in this incident at United States (multiple hotel chains).
Has anyone responded to FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.