Ion 3D— 510(k) K240086

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K240086 for Ion 3D, Substantially Equivalent on 2024-02-08. Applicant: SurGenTec, LLC. Device class: Unclassified.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-01-11
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MRW

K261209 — Ion-L2026-06-11
K253676 — CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)2026-05-14
K253432 — DiversiVy Facet Screw System2026-03-19
K251714 — Ion-C2026-01-16
K250679 — FFX Facet Fixation System2025-12-04

More clearances from SurGenTec, LLC

K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K261381 — TiLink-L SI Joint Fusion System2026-08-24
K262121 — Ion-L Navigated Instruments2026-07-24
K260329 — Ion-C Navigation Instruments2026-05-22
K253604 — TiLink-L Navigation Instruments2026-03-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.