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Regulatory Status: The PureSpin is an FDA cleared 510 (K) Class II medical device. PureSpin PRP® is intended for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograph or allograft bone prior to application to an orthopedic surgical site. 510 (K ) number BK050055.