Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach

Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach is an FDA 510(k)-cleared medical device (K143085) manufactured by Stryker Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2015. Regulation: 8.