K142980 - Proficient (TM) Facet Screw Spine System (FDA 510(k) Clearance)

K142980 is an FDA 510(k) clearance for the Proficient (TM) Facet Screw Spine System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 93 days - within the typical 510(k) review window.

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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