Consolidated Operating Room Equipment (CORE) 2 Console

About This 510(k) Submission

K243958 is an FDA 510(k) clearance for the Consolidated Operating Room Equipment (CORE) 2 Console, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 21, 2025, 88 days after receiving the submission on December 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.