SurGenTec, LLC
Medical device manufacturer in Boca Raton, FL.
31510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | 08/26/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 08/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | 07/24/2026SE |
| K261209 | Ion-LMRW · Traditional | 06/11/2026SE |
| K260329 | Ion-C Navigation InstrumentsOLO · Traditional | 05/22/2026SE |
| K253604 | TiLink-L Navigation InstrumentsOLO · Traditional | 03/20/2026SE |
| K251714 | Ion-CMRW · Traditional | 01/16/2026SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | 07/02/2025SE |
| K243949 | OsteoFlo HydroFiberMQV · Traditional | 05/28/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 04/24/2025SE |
| K243580 | GraftGun Universal Graft Delivery System (GDS)FMF · Traditional | 02/05/2025SE |
| K243835 | TiLink-P SI Joint Fusion SystemOUR · Special | 12/27/2024SE |
| K242797 | OsteoFlo HydroFiberMQV · Traditional | 12/23/2024SE |
| K243265 | Ion 3DMRW · Special | 12/04/2024SE |
| K242414 | TiLink-P Joint Fusion SystemOUR · Traditional | 11/21/2024SE |
| K242141 | TiLink-P SI Joint Fusion SystemOUR · Special | 08/21/2024SE |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 08/09/2024SE |
| K241416 | Ion 3DMRW · Special | 06/17/2024SE |
| K240720 | TiLink-P SI Joint Fusion SystemOUR · Special | 04/11/2024SE |
| K240086 | Ion 3DMRW · Special | 02/08/2024SE |
| K231716 | OsteoFlo® HydroPuttyMQV · Traditional | 10/02/2023SE |
| K230857 | TiLink-P SI Joint Fusion SystemOUR · Traditional | 09/25/2023SE |
| K231831 | TiLink-L Joint Fusion SystemOUR · Special | 08/03/2023SE |
| K230446 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 06/07/2023SE |
| K211855 | Ion Facet Screw SystemMRW · Traditional | 02/25/2022SE |
| K201900 | 3D GraftRasp SystemFMF · Traditional | 09/03/2020SE |
| K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftMQV · Traditional | 08/14/2020SE |
| K200431 | 3D GraftRasp SystemFMF · Traditional | 05/18/2020SE |
| K190163 | ALARA Neuro Access KitPDQ · Traditional | 07/16/2019SE |
| K180937 | Graftgun Universal Graft Delivery SystemFMF · Special | 05/10/2018SE |
| K170675 | Graftgun Universal Graft Delivery SystemFMF · Traditional | 07/19/2017SE |