Curiteva, Inc.: FDA clearances and approvals
Curiteva, Inc. has 15 FDA 510(k) clearances (first 2018, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time: 61 days. Since 2017 its median was 61 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 4 | 56 |
| 2019 | 1 | 54 |
| 2020 | 0 | — |
| 2021 | 1 | 211 |
| 2022 | 0 | — |
| 2023 | 3 | 85 |
| 2024 | 3 | 57 |
| 2025 | 1 | 90 |
| 2026 | 2 | 108 |
Review time against the same product codes
Since 2017, Curiteva, Inc.'s cleared 510(k)s took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Curiteva, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | ODP | 2026-01-16 | 186 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | ODP | 2026-01-15 | 29 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | OVD | 2025-06-18 | 90 |
| K243137 | Curiteva Porous PEEK Laminoplasty System | NQW | 2024-10-28 | 28 |
| K233360 | Curiteva Thoracolumbar Plate System | KWQ | 2024-02-29 | 153 |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | MAX | 2024-01-18 | 57 |
| K231232 | Curiteva Laminoplasty System | NQW | 2023-06-28 | 61 |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | ODP | 2023-02-13 | 510 |
| K223200 | Curiteva Navigation System | OLO | 2023-01-06 | 85 |
| K210402 | Curiteva Sacroiliac Joint Fusion System | OUR | 2021-09-09 | 211 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Curiteva, 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 Curiteva, Inc. have?
Curiteva, Inc. has 15 FDA 510(k) clearances (first 2018, latest 2026), across 8 product codes in 1 review panel.
How long does FDA take to clear Curiteva, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Curiteva, Inc.'s cleared 510(k)s is 61 days. Since 2017: 61 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Curiteva, Inc. make?
Its most frequent FDA product codes are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Has Curiteva, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Curiteva, Inc. Related entities may recall under other names.
Next steps
- See all 15 Curiteva, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ODP, Curiteva, 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.