← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OLO — Orthopedic Stereotaxic Instrument
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
DEVICE CLASS
Class II
REGULATION
21 CFR 882.4560
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
79
510(K)/PMA CLEARANCES
510k: 79
0
RECALL ENTRIES
Recent clearances
K261852Ortoma AB · 510k2026-07-01
K253921Silony Medical GmbH · 510k2026-06-26
K260480Depuy Ireland UC · 510k2026-06-25
K260369LEM Surgical AG · 510k2026-06-20
K261665Providence Medical Technology, Inc. · 510k2026-06-18
K260571Life Spine, Inc. · 510k2026-06-02
K261060Tyber Medical, LLC · 510k2026-05-29
K254157Medos International SARL · 510k2026-05-26
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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