FDA product code OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical
OVE is the FDA product code for intervertebral fusion device with integrated fixation, cervical. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel. FDA has cleared 166 510(k) submissions under OVE, 52 in the last five years, from 99 different applicants. The average 510(k) review took 134 days (median 116); 99 days on average over the last three years. FDA has posted 12 recalls for OVE devices, 1 initiated in the last five years.
Definition
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Classification
| Field | Value |
|---|---|
| Device name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class II |
| Regulation | 21 CFR 888.3080 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OVE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 91 |
| 2018 | 7 | 120 |
| 2019 | 7 | 94 |
| 2020 | 13 | 146 |
| 2021 | 10 | 126 |
| 2022 | 10 | 170 |
| 2023 | 16 | 147 |
| 2024 | 6 | 61 |
| 2025 | 10 | 114 |
| 2026 | 10 | 121 |
Compare with all 510(k) review times · Search every OVE clearance
Top OVE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| SeaSpine Orthopedics Corporation | 8 | 2023-11-28 |
| Genesys Spine | 6 | 2025-02-07 |
| Globus Medical, Inc. | 4 | 2025-12-22 |
| Life Spine, Inc. | 4 | 2023-10-19 |
| Nu Vasive, Incorporated | 4 | 2019-11-13 |
94 more applicants have OVE clearances. See the full list in Caduvo.
Most recent OVE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261882 | Osseus Fusions Systems, LLC | Pisces-SC Standalone Cervical Interbody System | 2026-08-21 | 77 |
| K261451 | ZSFab, Inc. | ZSAlign Cervical Interbody System | 2026-07-31 | 91 |
| K262094 | Evolution Spine | E3D-C Interbody System | 2026-07-22 | 30 |
| K261279 | Nexus Spine | DeltaNEC Interbody System | 2026-06-22 | 66 |
| K252982 | Avalign Technologies, Inc. | CONDUIT ZERO-P VA Secured Spacer System | 2026-06-18 | 274 |
Recalls for OVE devices
12 product recalls in 12 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code OVE?
OVE is the FDA product code for intervertebral fusion device with integrated fixation, cervical. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel.
What device class is OVE?
Class II, regulation 21 CFR 888.3080. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVE?
Across 166 cleared submissions the average was 134 days from receipt to decision (median 116).
Which companies have the most OVE clearances?
SeaSpine Orthopedics Corporation (8); Genesys Spine (6); Globus Medical, Inc. (4); Life Spine, Inc. (4); Nu Vasive, Incorporated (4).
Have OVE devices been recalled?
Yes: 12 product recalls across 12 recall events; the most recent began 2024-08-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OVE
- Run a recall and safety report across every OVE manufacturer
- Watch product code OVE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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