The FDA said the KneeAlign system is substantially equivalent to currently marketed computerassisted surgical (CAS) systems.
Read OrthAlign’s release about FDA clearance of KneeAlign.
FDA Allows Market Clearance for OrthAlign’s KneeAlign CAS System
OrthAlign has received a 510(k) clearance from the FDA to market the KneeAlign disposable computerassisted surgical navigation system for total knee arthroplasty procedures, according to a release by the company.
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