Foundation Surgical Group, Inc.: FDA clearances and approvals
Foundation Surgical Group, Inc. has 5 FDA 510(k) clearances (first 2024, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 104 days. Since 2017 its median was 104 days, against 96 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 2 | 149 |
| 2025 | 0 | — |
| 2026 | 3 | 60 |
Review time against the same product codes
Since 2017, Foundation Surgical Group, Inc.'s cleared 510(k)s took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Foundation Surgical Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous System | MQP | 2026-07-31 | 60 |
| K261809 | Interwedge® Standalone Lateral | OVD | 2026-07-31 | 60 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | OLO | 2026-04-16 | 104 |
| K241468 | Vertiwedge® Intraosseous System | MQP | 2024-11-07 | 167 |
| K241487 | Interwedge® Standalone Lateral | OVD | 2024-10-02 | 131 |
Recalls
openFDA lists no recalls under a recalling firm named Foundation Surgical Group, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Foundation Surgical Group, Inc. have?
Foundation Surgical Group, Inc. has 5 FDA 510(k) clearances (first 2024, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Foundation Surgical Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Foundation Surgical Group, Inc.'s cleared 510(k)s is 104 days. Since 2017: 104 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does Foundation Surgical Group, Inc. make?
Its most frequent FDA product codes are MQP (Spinal Vertebral Body Replacement Device, 2); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2); OLO (Orthopedic Stereotaxic Instrument, 1).
Has Foundation Surgical Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Foundation Surgical Group, Inc. Related entities may recall under other names.
Next steps
- See all 5 Foundation Surgical Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQP, Foundation Surgical Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.