FDA product code · Orthopedic · Class 2
OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical
OVE is FDA's product code for "Intervertebral Fusion Device With Integrated Fixation, Cervical": a Class 2 device classified under 21 CFR 888.3080, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for OVE
Across 90 510(k) clearances under OVE decided from 2018-01-01 to 2026-10-06, the median was 92 days from FDA receipt to decision. Half took between 58 and 165 days, and 80% were decided within 198 days. These are past clearances, not a forecast for a new submission.
| Fastest | 7 |
|---|---|
| 25th percentile | 58 |
| Median | 92 |
| 75th percentile | 165 |
| 80th percentile | 198 |
| 90th percentile | 259 |
| Slowest | 472 |
| Year | Median days | n |
|---|---|---|
| 2018 | 105 | 7 |
| 2019 | 87 | 7 |
| 2020 | 149 | 13 |
| 2021 | 93 | 10 |
| 2022 | 144 | 10 |
| 2023 | 97 | 16 |
| 2024 | 56 | 6 |
| 2025 | 105 | 10 |
| 2026 (to 10-06, partial) | 77 | 11 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OVE in the public FDA record
| 510(k) clearances, all years | 166 |
|---|---|
| Device recalls | 12 |
| Establishment listings | 764 |
| GUDID device identifiers | 17,973 |
Counts of records, not of devices or events. Adverse event reports for OVE are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OVE
8 FDA recognized consensus standards cite OVE, among them ASTM F2267-04 (Reapproved 2018); ASTM F2077-18; ASTM F3292-19. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-185 ASTM F2267-04 (Reapproved 2018) — Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- 11-347 ASTM F2077-18 — Test Methods for Intervertebral Body Fusion Devices
- 11-369 ASTM F3292-19 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
- 11-390 ISO 23089-2 First edition 2021-05 — Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
- 11-418 ASTM F3631-24 — Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
- 11-421 ASTM F2077-24 — Standard Test Methods for Intervertebral Body Fusion Devices
- 11-423 ASTM F2267-24 — Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.