510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232572Substantially Equivalent

Kalitec Navigated Instrument System

Kalitec Direct, LLC Doing Business AS Kalitec Medical, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232572 is the FDA 510(k) clearance record for Kalitec Navigated Instrument System, a class II device, cleared for Kalitec Direct, LLC Doing Business AS Kalitec Medical 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 Kalitec Direct, LLC Doing Business AS Kalitec Medical. As of , FDA records show no recalls naming K232572.

Clearance record

Decision date
Received
(111 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Kalitec Direct, LLC Doing Business AS Kalitec Medical 618 E. S. St., Suite 500, Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
44 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 20260
October 20260