K051856 - TRANS1 FACET SCREWS (FDA 510(k) Clearance)

K051856 is an FDA 510(k) clearance for the TRANS1 FACET SCREWS. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on September 26, 2005 after a review of 80 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.

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