Accel Spine: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Accel Spine” (first 2012, latest 2014), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 109 days. 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 | 6 | 119 |
| 2013 | 3 | 35 |
| 2014 | 1 | 75 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Accel Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140219 | PICASSO II MIS SPINAL SYSTEM | NKB | 2014-04-14 | 75 |
| K131981 | CEZANNE II INTERBODY FUSION SYSTEM | MAX | 2013-10-09 | 103 |
| K132366 | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS | KWQ | 2013-09-03 | 35 |
| K132365 | SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION | MNI | 2013-08-20 | 21 |
| K121567 | ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | MAX | 2012-09-26 | 120 |
| K121568 | DALI SPINAL FIXATION SYSTEM | NKB | 2012-09-21 | 115 |
| K121078 | VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-09-13 | 157 |
| K121136 | RENOIR POSTERIOR CERVIAL FIXATION SYSTEM | KWP | 2012-08-09 | 118 |
| K120714 | PICASSO MIS SPINAL FIXATION SYSTEM | NKB | 2012-08-09 | 154 |
| K121569 | MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM | ODP | 2012-07-27 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Accel 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 Accel Spine?
FDA lists 10 510(k) clearances under the applicant name “Accel Spine” (first 2012, latest 2014), across 6 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 Accel Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accel Spine is 109 days.
Which FDA product codes appear under Accel Spine?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 10 Accel Spine clearances with predicates and recalls
- Run predicate analysis for product code NKB, Accel 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.