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510(k) K223673

Device
Surgeon Controlled Arm
Applicant
Levita Magnetics International Corp
510(k) number
K223673
Product code
PNL
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-04
Date received
2022-12-07
Regulation
878.4815
Classification name
Magnetic Surgical System
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alberto Rodriguez-Navarro, MD
Address
4055-A Campbell Ave. Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252435Magnetic Surgical SystemLevita Magnetics International Corp2025-09-26
K250746Magnetic Surgical SystemLevita Magnetics International Corp2025-06-07
K191762Magnetic Surgical SystemLevita Magnetics International Corp2020-04-01
K190006Magnetic Surgical SystemLevita Magnetics International Corp2019-04-29
K180894Magnetic Surgical SystemLevita Magnetics International Corp2018-09-19
K171429Magnetic Surgical SystemLevita Magnetics International Corp2017-06-06
DEN150007Magnetic Surgical SystemLevita Magnetics International Corp2016-06-13