Ion-L Navigated Instruments— 510(k) K262121
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K262121 for Ion-L Navigated Instruments, Substantially Equivalent on 2026-07-24. Applicant: SurGenTec, LLC. Device class: 2.
Summary
SurGenTec's Ion-L Navigated Instruments are filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the instruments.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.
SurGenTec filed from Boca Raton, Florida. The decision came 31 calendar days after FDA received it (June 23 to July 24, 2026).
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boca Raton, FL, US
Recent devices under product code OLO
view allMore clearances from SurGenTec, LLC
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.