Company ยท US
Curiteva, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| 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 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Lamin Curiteva, Inc. | ODP |
| Jan 15, 2026 | K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System Curiteva, Inc. | ODP |
| Jun 18, 2025 | K250845 | Curiteva Porous PEEK Standalone ALIF System Curiteva, Inc. | OVD |
| Oct 28, 2024 | K243137 | Curiteva Porous PEEK Laminoplasty System Curiteva, Inc. | NQW |
| Feb 29, 2024 | K233360 | Curiteva Thoracolumbar Plate System Curiteva, Inc. | KWQ |
| Jan 18, 2024 | K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System Curiteva, Inc. | MAX |
| Jun 28, 2023 | K231232 | Curiteva Laminoplasty System Curiteva, Inc. | NQW |
| Feb 13, 2023 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System Curiteva, Inc. | ODP |
| Jan 6, 2023 | K223200 | Curiteva Navigation System Curiteva, Inc. | OLO |
| Sep 9, 2021 | K210402 | Curiteva Sacroiliac Joint Fusion System Curiteva, Inc. | OUR |
| Aug 28, 2019 | K191810 | Curiteva Pedicle Screw System Curiteva, Inc. | NKB |
| Dec 20, 2018 | K181589 | Curiteva Lumbar Interbody Fusion System Curiteva, LLC | MAX |
| Aug 3, 2018 | K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC | KWQ |
| Aug 2, 2018 | K181562 | Curiteva Anterior Cervical Plate System Curiteva, LLC | KWQ |
| Jul 9, 2018 | K181261 | Curiteva Cervical Interbody Fusion System Curiteva, LLC | ODP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||