Degen Medical: FDA clearances and approvals
Degen Medical has 18 FDA 510(k) clearances (first 2015, latest 2025), across 6 product codes in 1 review panel. Median 510(k) review time: 110 days. Since 2017 its median was 76 days, against 91 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 3 | 192 |
| 2016 | 1 | 85 |
| 2017 | 0 | — |
| 2018 | 1 | 45 |
| 2019 | 1 | 58 |
| 2020 | 1 | 222 |
| 2021 | 2 | 162 |
| 2022 | 2 | 40 |
| 2023 | 2 | 88 |
| 2024 | 2 | 186 |
| 2025 | 3 | 43 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Degen Medical's cleared 510(k)s took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
Review panels
- Orthopedic (18)
Most recent Degen Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | OVD | 2025-12-08 | 178 |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | ODP | 2025-10-10 | 43 |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | MAX | 2025-04-04 | 30 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | OVD | 2024-10-29 | 193 |
| K240326 | Solar Lumbar Interbody Fusion System | MAX | 2024-07-29 | 178 |
| K231199 | Solar Lumbar Interbody Fusion System | MAX | 2023-06-16 | 50 |
| K223418 | DeGen Impulse AM System | MAX | 2023-03-17 | 127 |
| K213918 | DeGen Navigated Instrumentation | OLO | 2022-02-09 | 56 |
| K213901 | Cyclops Anterior Cervical Plate System | KWQ | 2022-01-07 | 24 |
| K210090 | Impulse AM Interbody Fusion System | MAX | 2021-08-30 | 229 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Degen Medical.
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 Degen Medical have?
Degen Medical has 18 FDA 510(k) clearances (first 2015, latest 2025), across 6 product codes in 1 review panel.
How long does FDA take to clear Degen Medical's 510(k)s?
The median time from FDA receipt to decision across Degen Medical's cleared 510(k)s is 110 days. Since 2017: 76 days, versus 91 days for all cleared 510(k)s in the same product codes.
What devices does Degen Medical make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Has Degen Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Degen Medical. Related entities may recall under other names.
Next steps
- See all 18 Degen Medical clearances with predicates and recalls
- Run predicate analysis for product code MAX, Degen Medical'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.