SurGenTec, LLC: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “SurGenTec, LLC” (first 2017, latest 2026), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 98 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 135 |
| 2018 | 1 | 30 |
| 2019 | 1 | 166 |
| 2020 | 3 | 87 |
| 2021 | 0 | — |
| 2022 | 1 | 254 |
| 2023 | 4 | 108 |
| 2024 | 9 | 31 |
| 2025 | 4 | 102 |
| 2026 | 8 | 116 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SurGenTec, LLC took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | 8 | 8 |
| FMF | Syringe, Piston | 6 | 6 |
| MRW | System, Facet Screw Spinal Device | 6 | 6 |
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| KNW | Instrument, Biopsy | 2 | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| PDQ | Neurosurgical Nerve Locator | 1 | 1 |
Review panels
- Orthopedic (22)
- General Hospital (6)
- Neurology (2)
- General and Plastic Surgery (2)
Most recent SurGenTec, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252995 | Durashield Device Kit | GZT | 2026-09-17 | 364 |
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | FMF | 2026-08-26 | 30 |
| K261381 | TiLink-L SI Joint Fusion System | OUR | 2026-08-24 | 119 |
| K262121 | Ion-L Navigated Instruments | OLO | 2026-07-24 | 31 |
| K261209 | Ion-L | MRW | 2026-06-11 | 59 |
| K260329 | Ion-C Navigation Instruments | OLO | 2026-05-22 | 112 |
| K253604 | TiLink-L Navigation Instruments | OLO | 2026-03-20 | 122 |
| K251714 | Ion-C | MRW | 2026-01-16 | 227 |
| K251720 | OsteoFlo HydroFiber | MQV | 2025-07-02 | 28 |
| K243949 | OsteoFlo HydroFiber | MQV | 2025-05-28 | 156 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named SurGenTec, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named SurGenTec, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06720948: The ION Facet Screw System Ambispective Evaluation (Enrolling by invitation, started 2025-01-31)
Frequently asked questions
How many FDA 510(k) clearances are listed under SurGenTec, LLC?
FDA lists 32 510(k) clearances under the applicant name “SurGenTec, LLC” (first 2017, latest 2026), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by SurGenTec, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name SurGenTec, LLC is 98 days. Since 2017: 98 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under SurGenTec, LLC?
The most frequent FDA product codes under this applicant name are OUR (Sacroiliac Joint Fixation, 8); FMF (Syringe, Piston, 6); MRW (System, Facet Screw Spinal Device, 6).
Next steps
- See all 32 SurGenTec, LLC clearances with predicates and recalls
- Run predicate analysis for product code OUR, SurGenTec, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.