Evolution Spine: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Evolution Spine” (first 2016, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 79 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 171 |
| 2017 | 1 | 55 |
| 2018 | 1 | 106 |
| 2019 | 1 | 127 |
| 2020 | 0 | — |
| 2021 | 1 | 59 |
| 2022 | 1 | 46 |
| 2023 | 1 | 125 |
| 2024 | 3 | 99 |
| 2025 | 1 | 209 |
| 2026 | 2 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Evolution Spine took a median 79 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Evolution Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262094 | E3D-C Interbody System | OVE | 2026-07-22 | 30 |
| K260038 | E3D-C Interbody System | OVE | 2026-02-04 | 29 |
| K250167 | Evolution Spine Navigation Instruments | OLO | 2025-08-18 | 209 |
| K241846 | E3D-C Interbody System | OVE | 2024-08-12 | 47 |
| K240368 | E3D-A Interbody System | OVD | 2024-05-15 | 99 |
| K232432 | E3D-A Interbody System | OVD | 2024-01-30 | 172 |
| K223146 | EVOLUTION SPINE Interbody System | OVD | 2023-02-07 | 125 |
| K220275 | EMERGE Anterior Cervical Plate System | KWQ | 2022-03-18 | 46 |
| K212405 | EMERGE Anterior Cervical Plate System | KWQ | 2021-09-30 | 59 |
| K182478 | Whistler Modular Pedicle Screw System | NKB | 2019-01-15 | 127 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Evolution Spine.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Evolution Devices, Inc. (1 510(k)s)
- Evolution Medical Technologies, LLC (1 510(k)s)
- Evolution Optiks Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Evolution Spine?
FDA lists 14 510(k) clearances under the applicant name “Evolution Spine” (first 2016, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Evolution Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Evolution Spine is 94 days. Since 2017: 79 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Evolution Spine?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 3); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 3).
Next steps
- See all 14 Evolution Spine clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Evolution Spine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.