FDA product code OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar
OVD is the FDA product code for intervertebral fusion device with integrated fixation, lumbar. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel. FDA has cleared 205 510(k) submissions under OVD, 56 in the last five years, from 104 different applicants. The average 510(k) review took 129 days (median 112); 105 days on average over the last three years. FDA has posted 36 recalls for OVD devices, 26 initiated in the last five years.
Definition
Intended to stabilize lumbar 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, Lumbar |
| 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 OVD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 12 | 130 |
| 2018 | 14 | 130 |
| 2019 | 12 | 132 |
| 2020 | 14 | 103 |
| 2021 | 7 | 149 |
| 2022 | 14 | 141 |
| 2023 | 12 | 107 |
| 2024 | 12 | 106 |
| 2025 | 10 | 103 |
| 2026 | 8 | 106 |
Compare with all 510(k) review times · Search every OVD clearance
Top OVD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Globus Medical, Inc. | 11 | 2026-04-29 |
| Nu Vasive, Incorporated | 10 | 2023-06-16 |
| K2m, Inc. | 6 | 2019-10-03 |
| Medacta International S.A. | 5 | 2026-05-05 |
| Kyocera Medical Technologies, Inc. | 4 | 2026-07-15 |
99 more applicants have OVD clearances. See the full list in Caduvo.
Most recent OVD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262025 | INNO Holdings Inc. DBA Innovasis | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | 2026-09-11 | 87 |
| K261408 | Elevation Spine | SABER-XA System | 2026-08-03 | 95 |
| K261809 | Foundation Surgical Group | Interwedge® Standalone Lateral | 2026-07-31 | 60 |
| K261353 | Kyocera Medical Technologies, Inc. | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | 2026-07-15 | 82 |
| K260810 | Tyber Medical, LLC | Anteralign LS coverplate | 2026-06-10 | 90 |
Recalls for OVD devices
36 product recalls in 20 recall events; 26 initiated in the last five years and 21 still open. Most recent: 2026-04-23.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 15 |
| 2024 | 3 |
| 2025 | 6 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OVD?
OVD is the FDA product code for intervertebral fusion device with integrated fixation, lumbar. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel.
What device class is OVD?
Class II, regulation 21 CFR 888.3080. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVD?
Across 205 cleared submissions the average was 129 days from receipt to decision (median 112).
Which companies have the most OVD clearances?
Globus Medical, Inc. (11); Nu Vasive, Incorporated (10); K2m, Inc. (6); Medacta International S.A. (5); Kyocera Medical Technologies, Inc. (4).
Have OVD devices been recalled?
Yes: 36 product recalls across 20 recall events; the most recent began 2026-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OVD
- Run a recall and safety report across every OVD manufacturer
- Watch product code OVD 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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