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 |
| K211855 |
06/16/2021 |
Ion Facet Screw System |
SurGenTec, LLC |
| K242141 |
07/22/2024 |
TiLink-P SI Joint Fusion System |
SurGenTec, LLC |
| K180937 |
04/10/2018 |
Graftgun Universal Graft Delivery System |
Surgentec, LLC |
| K241416 |
05/17/2024 |
Ion 3D |
SurGenTec, LLC |
| K240086 |
01/11/2024 |
Ion 3D |
SurGenTec, LLC |
| K240664 |
03/08/2024 |
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) |
SurGenTec, LLC |
| K240720 |
03/15/2024 |
TiLink-P SI Joint Fusion System |
SurGenTec, LLC |
| K243949 |
12/23/2024 |
OsteoFlo HydroFiber |
SurGenTec, LLC |
| K251720 |
06/04/2025 |
OsteoFlo HydroFiber |
SurGenTec, LLC |
| K243265 |
10/15/2024 |
Ion 3D |
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 |
| K230857 |
03/29/2023 |
TiLink-P SI Joint Fusion System |
Surgentec, LLC |
| K231716 |
06/13/2023 |
OsteoFlo« HydroPuttyÖ |
SurGenTec, LLC |
| K242797 |
09/16/2024 |
OsteoFlo HydroFiber |
SurGenTec, LLC |
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