K120597 - KOMPREDA (FDA 510(k) Clearance)

K120597 is an FDA 510(k) clearance for the KOMPREDA. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Custom Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Custom Spine, Inc. devices