K121551 - RESOLUTE FACET SCREW SYSTEM (FDA 510(k) Clearance)

K121551 is an FDA 510(k) clearance for the RESOLUTE FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Neurostructures, LLC (Colorado Springs, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 151 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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