FDA 510(k) Applications Submitted by SurGenTec, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K230446 02/21/2023 TiLink-L SI Joint Fusion System Surgentec, LLC
K230857 03/29/2023 TiLink-P SI Joint Fusion System Surgentec, LLC
K211855 06/16/2021 Ion Facet Screw System SurGenTec, LLC
K180937 04/10/2018 Graftgun Universal Graft Delivery System Surgentec, LLC
K200064 01/13/2020 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft SurGenTec, LLC
K190163 01/31/2019 ALARA Neuro Access Kit SurGenTec, LLC
K170675 03/06/2017 Graftgun Universal Graft Delivery System Surgentec, LLC
K231716 06/13/2023 OsteoFlo« HydroPuttyÖ SurGenTec, LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact