FDA product code ODP: Intervertebral Fusion Device With Bone Graft, Cervical
ODP is the FDA product code for intervertebral fusion device with bone graft, cervical. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel. FDA has cleared 354 510(k) submissions under ODP, 86 in the last five years, from 205 different applicants. The average 510(k) review took 144 days (median 116); 126 days on average over the last three years. FDA has posted 11 recalls for ODP devices, 5 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.
Classification
| Field | Value |
|---|---|
| Device name | Intervertebral Fusion Device With Bone Graft, 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 ODP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 33 | 114 |
| 2018 | 25 | 149 |
| 2019 | 22 | 94 |
| 2020 | 14 | 119 |
| 2021 | 18 | 137 |
| 2022 | 12 | 160 |
| 2023 | 34 | 204 |
| 2024 | 10 | 97 |
| 2025 | 11 | 132 |
| 2026 | 19 | 150 |
Compare with all 510(k) review times · Search every ODP clearance
Top ODP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthofix, Inc. | 9 | 2021-08-31 |
| Nu Vasive, Incorporated | 8 | 2023-07-11 |
| Gbs Commonwealth Co., Ltd. | 7 | 2023-12-20 |
| Globus Medical, Inc. | 7 | 2022-10-21 |
| Medtronic Sofamor Danek USA, Inc. | 7 | 2016-03-28 |
200 more applicants have ODP clearances. See the full list in Caduvo.
Most recent ODP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262595 | Wenzel Spine, Inc. | VariLift-C Cervical Interbody Fusion System | 2026-08-26 | 30 |
| K262489 | L&K BIOMED Co., Ltd. | BluEX Cervical Expandable Cage System | 2026-08-18 | 29 |
| K253041 | Fims Co., Ltd. | 3d Cage Cervical | 2026-07-23 | 304 |
| K262061 | Stryker Spine | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | 2026-07-17 | 29 |
| K254130 | C.A. Medical, LLC | C.A. Medical Interbody Fusion System | 2026-07-08 | 198 |
Recalls for ODP devices
11 product recalls in 8 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 3 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code ODP?
ODP is the FDA product code for intervertebral fusion device with bone graft, cervical. It is a Class II device, regulated under 21 CFR 888.3080 and reviewed by the Orthopedic panel.
What device class is ODP?
Class II, regulation 21 CFR 888.3080. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODP?
Across 354 cleared submissions the average was 144 days from receipt to decision (median 116).
Which companies have the most ODP clearances?
Orthofix, Inc. (9); Nu Vasive, Incorporated (8); Gbs Commonwealth Co., Ltd. (7); Globus Medical, Inc. (7); Medtronic Sofamor Danek USA, Inc. (7).
Have ODP devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code ODP
- Run a recall and safety report across every ODP manufacturer
- Watch product code ODP 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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