K060963 - TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) (FDA 510(k) Clearance)

K060963 is an FDA 510(k) clearance for the TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS M.... Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Twin Star Medical (St. Paul, US). The FDA issued a Cleared decision on June 6, 2006 after a review of 60 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.

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