TiLink-L Navigation Instruments— 510(k) K253604
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K253604 for TiLink-L Navigation Instruments, Substantially Equivalent on 2026-03-20. Applicant: SurGenTec, LLC. Device class: 2.
Summary
SurGenTec's TiLink-L Navigation Instruments are filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the individual instruments.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
SurGenTec filed from Boca Raton, Florida. The decision came 122 calendar days after FDA received it (November 18, 2025 to March 20, 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
- Traditional
- 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.