K121850 - Typhoon(TM) Facet Screw Fixation System (FDA 510(k) Clearance)

K121850 is an FDA 510(k) clearance for the Typhoon(TM) Facet Screw Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.