510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K202184Substantially Equivalent

Practical Navigation Surgical Guidance System (PNSGS)

Practical Navigation, LLC, Superior CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202184 is the FDA 510(k) clearance record for Practical Navigation Surgical Guidance System (PNSGS), a class II device, cleared for Practical Navigation, LLC on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list one 510(k) clearance for Practical Navigation, LLC. As of , FDA records show no recalls naming K202184.

Clearance record

Decision date
Received
(204 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Practical Navigation, LLC 720 E. Wiggins St., Superior CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
45 clearances under product code OLO in the twelve months to October 2026, February 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code OLO, trailing twelve months
MonthClearances
November 20252
December 20254
January 20262
February 202610
March 20267
April 20262
May 20265
June 20265
July 20266
August 20261
September 20261
October 20260