Medacta International is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medacta International - FDA 510(k) Cleared Devices
Medacta International, is a global medical device company specializing in orthopedic surgical solutions. The company operates with a manufacturing facility in San Diego, US. Medacta develops implants and instrumentation for joint replacement, spine surgery, and related orthopedic procedures.
The company has received 39 FDA 510(k) clearances from 39 total submissions. All submissions focused on orthopedic devices. Medacta's FDA 510(k) clearance activity spans from 2011 to 2016, establishing a regulatory track record in joint and spine implant technologies.
Recent cleared devices include systems for anterior lumbar interbody fusion, pedicle screw fixation, knee arthroplasty, and hip reconstruction. The company's product portfolio emphasizes minimally invasive surgical approaches and patient-specific solutions across hip, knee, shoulder, and spine applications.
This regulatory profile is presented as a historical record. Explore the complete list of device names, product codes, and individual clearance dates in the database.
FDA 510(k) Regulatory Record - Medacta International
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