K031657 - STRYKER SPINE OASYS BONE SCREW (FDA 510(k) Clearance)

K031657 is an FDA 510(k) clearance for the STRYKER SPINE OASYS BONE SCREW. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 86 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 Howmedica Osteonics Corp. devices