Cleared Traditional

K200064 - OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
(FDA 510(k) Clearance)

K200064 · SurGenTec, LLC · Orthopedic

Aug 2020

Decision

214d

Days

Class 2

Risk

K200064 is an FDA 510(k) clearance for the OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on August 14, 2020, 214 days after receiving the submission on January 13, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K200064 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2020
Decision Date	August 14, 2020
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF