FDA 510(k), K202184, Practical Navigation Surgical Guidance System (PNSGS)

510(K) Number: K202184
Device Name: Practical Navigation Surgical Guidance System (PNSGS)
Manufacturer: Practical Navigation, LLC
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 08/04/2020
Decision Date: 02/24/2021
Regulation Medical Specialty: Neurology

106 pages (3,088 of 3,194 original pages are fully redacted)