OLOClass II

Orthopedic Stereotaxic Instrument

21 CFR 882.4560 / Neurology

OLO is the FDA product code for Orthopedic Stereotaxic Instrument, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". As of 2026-09-10, FDA records hold 440 510(k) clearances under this code, the most recent dated 2026-08-20, and 113 recalls.

Classification record

Product code: OLO
Device name: Orthopedic Stereotaxic Instrument
FDA definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Regulation: 21 CFR 882.4560
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 440
Ingested recalls: 113

Clearances, product code OLO

By decision year

440 clearances under product code OLO with a decision year between 2009 and 2026, 2023 the highest year at 45.

Show the numbers

510(k) clearances under FDA product code OLO by decision year
Year	Clearances
2009	11
2010	9
2011	11
2012	7
2013	7
2014	10
2015	10
2016	14
2017	33
2018	24
2019	35
2020	34
2021	28
2022	40
2023	45
2024	44
2025	40
2026	38

Applicants with the most clearances

Product code OLO

Applicants holding the most 510(k) clearances under product code OLO
Applicant	Clearances
Mako Surgical Corp.	23
Brainlab, Inc.	21
Think Surgical Inc.	19
Blue Belt Technologies, Inc.	18
Medtronic Sofamor Danek USA Inc	15
Globus Medical, Inc.	13
Medos International SARL	12
Medtronic Navigation, Inc	12
OrthAlign, Inc.	12
Stryker Corp.	11

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 331 companies shown, in name order