K161798 - FacetBRIDGE® System (FDA 510(k) Clearance)

K161798 is an FDA 510(k) clearance for the FacetBRIDGE® System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on August 4, 2016 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ldr Spine USA, Inc. devices