Total clearances
5
2024-10-02 → 2026-07-31
Name variants in FDA filings: Foundation Surgical Group, Inc. / Foundation Surgical Group
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| OVD |
Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Class II |
Orthopedic |
2 |
2026-07-31 |
| MQP |
Spinal Vertebral Body Replacement Device |
Class II |
Orthopedic |
2 |
2026-07-31 |
| OLO |
Orthopedic Stereotaxic Instrument |
Class II |
Neurology |
1 |
2026-04-16 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-31 |
K261810 |
Vertiwedge® Intraosseous System |
MQP |
Class II |
Orthopedic |
| 2026-07-31 |
K261809 |
Interwedge® Standalone Lateral |
OVD |
Class II |
Orthopedic |
| 2026-04-16 |
K260011 |
Foundation Surgical Navigated Lateral Disc Prep Instruments |
OLO |
Class II |
Neurology |
| 2024-11-07 |
K241468 |
Vertiwedge® Intraosseous System |
MQP |
Class II |
Orthopedic |
| 2024-10-02 |
K241487 |
Interwedge® Standalone Lateral |
OVD |
Class II |
Orthopedic |