Ion 3D
FDA 510(k) clearance K240086 · decided 2024-02-08
Clearance details
- K-number
- K240086
- Device name
- Ion 3D
- Applicant
- SurGenTec, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-01-11
- Decision date
- 2024-02-08
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MRW
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ion-L (K261209) | SurGenTec, LLC | 2026-06-11 |
| CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (K253676) | Providence Medical Technology, Inc. | 2026-05-14 |
| DiversiVy™ Facet Screw System (K253432) | Vy Spine, LLC | 2026-03-19 |
| Ion-C (K251714) | SurGenTec, LLC | 2026-01-16 |
| FFX Facet Fixation System (K250679) | Sc Medica | 2025-12-04 |
| CORUS-LX Implant (K253190) | Providence Medical Technology, Inc. | 2025-11-20 |
| FFX Facet Fixation System (K252153) | Sc Medica | 2025-10-16 |
| CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (K251885) | Providence Medical Technology, Inc. | 2025-07-10 |
| Arthrex Spine Compression FT Screw (K250920) | Arthrex, Inc. | 2025-05-22 |
| The Karma® Fixation System (K242527) | Spinal Elements, Inc. | 2025-05-21 |
| AERO MIS Facet Fusion System (K243865) | Aurora Spine | 2025-03-24 |
| Ion 3D (K243265) | SurGenTec, LLC | 2024-12-04 |
Recalls involving this device
No recalls on record reference this clearance.