Surgentec
Surgentec appears in FDA public data with 0 recalls, 32 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 17, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 32
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252995 | Durashield Device Kit | September 17, 2026 |
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | August 26, 2026 |
| K261381 | TiLink-L SI Joint Fusion System | August 24, 2026 |
| K262121 | Ion-L Navigated Instruments | July 24, 2026 |
| K261209 | Ion-L | June 11, 2026 |
| K260329 | Ion-C Navigation Instruments | May 22, 2026 |
| K253604 | TiLink-L Navigation Instruments | March 20, 2026 |
| K251714 | Ion-C | January 16, 2026 |
| K251720 | OsteoFlo HydroFiber | July 2, 2025 |
| K243949 | OsteoFlo HydroFiber | May 28, 2025 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | April 24, 2025 |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | February 5, 2025 |
| K243835 | TiLink-P SI Joint Fusion System | December 27, 2024 |
| K242797 | OsteoFlo HydroFiber | December 23, 2024 |
| K243265 | Ion 3D | December 4, 2024 |
| K242414 | TiLink-P Joint Fusion System | November 21, 2024 |
| K242141 | TiLink-P SI Joint Fusion System | August 21, 2024 |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | August 9, 2024 |
| K241416 | Ion 3D | June 17, 2024 |
| K240720 | TiLink-P SI Joint Fusion System | April 11, 2024 |