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SurGenTec

SurGenTec wins FDA nod for bone marrow aspirate kit

August 23, 2024 By Sean Whooley

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate kit. Boca Raton, Florida-based SurGenTec says its B-MAN kit offers a cutting-edge approach to bone marrow aspiration. It utilizes a centrifuge-free method to collect high-quality aspirate with minimal contaminants. The kit’s integrated, diamond-tip trocar works simultaneously with CELLect filtration […]

Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance, Spine Tagged With: FDA, SurGenTec

SurGenTec wins FDA nod for hydrophilic synthetic bone graft

March 7, 2024 By Sean Whooley

SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft. OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received FDA clearance in 2020. SurGenTec said that, along with clearance, it can report the first implantations of the new graft as well. The new bone graft offers what the company […]

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance Tagged With: SurGenTec

FDA clears SurGenTec synthetic bone graft

August 26, 2020 By Sean Whooley

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft. Boca Raton, Fla.-based SurGenTec said in a news release that its novel OsteoFlo NanoPutty bone graft features the world’s first and only quadphasic synthetic bone graft particles with nano-surface technology for providing an “optimal resorption profile with […]

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance Tagged With: FDA, SurGenTec

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