K211855 - Ion Facet Screw System (FDA 510(k) Clearance)

K211855 is an FDA 510(k) clearance for the Ion Facet Screw System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on February 25, 2022 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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