K082795 - SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (FDA 510(k) Clearance)

K082795 is an FDA 510(k) clearance for the SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Interventional Spine, Inc. (Irvine, US). The FDA issued a Cleared decision on December 12, 2008 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.

View all Interventional Spine, Inc. devices