Xenco Medical, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Xenco Medical, LLC” (first 2014, latest 2025), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 121 days, against 89 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 |
|---|---|---|
| 2014 | 1 | 156 |
| 2015 | 4 | 64 |
| 2016 | 3 | 98 |
| 2017 | 1 | 85 |
| 2018 | 2 | 227 |
| 2019 | 2 | 110 |
| 2020 | 0 | — |
| 2021 | 1 | 56 |
| 2022 | 0 | — |
| 2023 | 1 | 250 |
| 2024 | 0 | — |
| 2025 | 1 | 63 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xenco Medical, LLC took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Xenco Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody System | ODP | 2025-01-29 | 63 |
| K223059 | Xenco Medical InterAlign Cervical Interbody System | OVE | 2023-06-07 | 250 |
| K213456 | Xenco Medical Multilevel CerviKit | KWQ | 2021-12-21 | 56 |
| K191074 | Sorrento Bone Graft Substitute | MQV | 2019-09-27 | 157 |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | MAX | 2019-04-18 | 62 |
| K173933 | Sorrento Bioglass Bone Graft Substitute | MQV | 2018-09-13 | 261 |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | MAX | 2018-08-24 | 193 |
| K170611 | SETx Pedicle Screw System | NKB | 2017-05-25 | 85 |
| K160313 | Xenco Medical Cervical Interbody System | OVE | 2016-10-21 | 259 |
| K161478 | Xenco Medical Posterior Cervical System | NKG | 2016-09-06 | 98 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Xenco Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Xenco Medical, LLC?
FDA lists 16 510(k) clearances under the applicant name “Xenco Medical, LLC” (first 2014, latest 2025), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xenco Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xenco Medical, LLC is 92 days. Since 2017: 121 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xenco Medical, LLC?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Next steps
- See all 16 Xenco Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code ODP, Xenco Medical, 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.