K092568 - SPARTAN S3 FACET SYSTEM (FDA 510(k) Clearance)

K092568 is an FDA 510(k) clearance for the SPARTAN S3 FACET SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Amendia, Inc. (Apple Valley, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 89 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.

View all Amendia, Inc. devices