Ion-L— 510(k) K261209
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K261209 for Ion-L, Substantially Equivalent on 2026-06-11. Applicant: SurGenTec, LLC. Device class: Unclassified.
Summary
SurGenTec's Ion-L is filed under MRW, facet screw spinal device systems. The record doesn't describe the product beyond its name and the code name.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Orthopedic review panel handled it as a Traditional 510(k).
SurGenTec filed from Boca Raton, Florida. Review took 59 calendar days (April 13 to June 11, 2026).
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Product code MRW
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Recent devices under product code MRW
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