K101364 - LANX FACET SCREW SYSTEM (FDA 510(k) Clearance)

K101364 is an FDA 510(k) clearance for the LANX FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on August 16, 2010 after a review of 94 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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