Eminent Spine: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Eminent Spine” (first 2009, latest 2025), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 108 days, against 90 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 252 |
| 2015 | 1 | 126 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 40 |
| 2021 | 1 | 59 |
| 2022 | 1 | 108 |
| 2023 | 2 | 320 |
| 2024 | 2 | 77 |
| 2025 | 2 | 260 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eminent Spine took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| OUR | Sacroiliac Joint Fixation | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Eminent Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250894 | Eminent Spine Posterior SI System | OUR | 2025-10-07 | 196 |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | NKB | 2025-04-28 | 325 |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | NKB | 2024-09-03 | 50 |
| K240505 | Eminent Spine SI Screw System | OUR | 2024-06-04 | 104 |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | MAX | 2023-05-16 | 110 |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | ODP | 2023-02-06 | 530 |
| K221936 | Standalone ALIF Interbody Fusion System | OVD | 2022-10-17 | 108 |
| K212853 | Cervical Stand-Alone System | OVE | 2021-11-05 | 59 |
| K201979 | Cervical Plate System | KWQ | 2020-08-25 | 40 |
| K143365 | Eminent Foot Plate System | HRS | 2015-03-30 | 126 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eminent 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eminent Spine?
FDA lists 15 510(k) clearances under the applicant name “Eminent Spine” (first 2009, latest 2025), across 9 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 Eminent Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eminent Spine is 104 days. Since 2017: 108 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eminent Spine?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Next steps
- See all 15 Eminent Spine clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Eminent 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.