K051949 - 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 (FDA 510(k) Clearance)

K051949 is an FDA 510(k) clearance for the 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 21 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.

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