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SurGenTec, LLC FDA Approvals
0 new drug approvals and 25 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Durashield Device Kit510(k)Sep 17, 2026Neurology |
| GraftGun Universal Graft Delivery System (GDS®)510(k)Aug 26, 2026General Hospital |
| TiLink-L SI Joint Fusion System510(k)Aug 24, 2026Orthopedic |
| Ion-L Navigated Instruments510(k)Jul 24, 2026Neurology |
| Ion-L510(k)Jun 11, 2026 |
| Ion-C Navigation Instruments510(k)May 22, 2026Neurology |
| TiLink-L Navigation Instruments510(k)Mar 20, 2026Neurology |
| Ion-C510(k)Jan 16, 2026 |
| OsteoFlo HydroFiber510(k)Jul 2, 2025Orthopedic |
| OsteoFlo HydroFiber510(k)May 28, 2025Orthopedic |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)510(k)Apr 24, 2025Gastroenterology, Urology |
| GraftGun Universal Graft Delivery System (GDS)510(k)Feb 5, 2025General Hospital |
| TiLink-P SI Joint Fusion System510(k)Dec 27, 2024Orthopedic |
| OsteoFlo HydroFiber510(k)Dec 23, 2024Orthopedic |
| Ion 3D510(k)Dec 4, 2024 |
| TiLink-P Joint Fusion System510(k)Nov 21, 2024Orthopedic |
| TiLink-P SI Joint Fusion System510(k)Aug 21, 2024Orthopedic |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)510(k)Aug 9, 2024Gastroenterology, Urology |
| Ion 3D510(k)Jun 17, 2024 |
| TiLink-P SI Joint Fusion System510(k)Apr 11, 2024Orthopedic |
| Ion 3D510(k)Feb 8, 2024 |
| OsteoFlo® HydroPutty510(k)Oct 2, 2023Orthopedic |
| TiLink-P SI Joint Fusion System510(k)Sep 25, 2023Orthopedic |
| TiLink-L SI Joint Fusion System510(k)Jun 7, 2023Orthopedic |
| Ion Facet Screw System510(k)Feb 25, 2022 |