Product code OLO: 510(k) clearances and predicates
Product code OLO covers Remex Spine Surgery Navigation - Universal Instruments. FDA lists 440 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
440 clearances on file under product code OLO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 40 |
| 2023 | 45 |
| 2024 | 44 |
| 2025 | 40 |
| 2026 so far | 38 |
Recent clearances
Newest OLO clearances in the FDA index, with applicant and decision date:
- K262506, Remex Spine Surgery Navigation - Universal Instruments, applicant Remex Medical Corp., decided 2026-08-20. FDA record
- K261410, Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)), applicant Suite 201, National Innovation Centre, decided 2026-07-30. FDA record
- K261205, SPINEART Navigation Instrument System, applicant Spineart SA, decided 2026-07-29. FDA record
- K261024, TMINI Miniature Robotic System, applicant THINK Surgical, Inc., decided 2026-07-24. FDA record
- K262121, Ion-L Navigated Instruments, applicant SurGenTec, LLC, decided 2026-07-24. FDA record
- K261113, Op.nĀ Spine Navigation and Robotic Guidance, applicant Ecential Robotics, decided 2026-07-22. FDA record
- K261852, OTS Hip, applicant Ortoma AB, decided 2026-07-01. FDA record
- K253921, VERTICALEĀ® Navigation Instruments, applicant Silony Medical GmbH, decided 2026-06-26. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)), SPINEART Navigation Instrument System. Watch new OLO clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code OLO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent OLO clearances include Remex Spine Surgery Navigation - Universal Instruments.
How many 510(k) clearances use product code OLO?
440 at the time this page was generated, from openFDA records.
How do I find a predicate device under OLO?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new OLO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.