Spinefrontier, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Spinefrontier, Inc.” (first 2007, latest 2020), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 108 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 | 2 | 84 |
| 2013 | 2 | 106 |
| 2014 | 5 | 188 |
| 2015 | 4 | 94 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 264 |
| 2019 | 0 | — |
| 2020 | 1 | 224 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spinefrontier, Inc. took a median 244 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
Review panels
- Orthopedic (24)
Most recent Spinefrontier, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | MAX | 2020-06-19 | 224 |
| K172484 | A-CIFT SoloFuse | OVE | 2018-05-08 | 264 |
| K151198 | A-CIFT SoloFuse | OVE | 2015-07-17 | 73 |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | MAX | 2015-05-13 | 250 |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | OUR | 2015-04-24 | 109 |
| K143377 | PedFuse Pedicle Screw System | MNH | 2015-02-12 | 79 |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | ODP | 2014-11-25 | 188 |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | ODP | 2014-10-20 | 87 |
| K141337 | ARENA-C | ODP | 2014-09-08 | 110 |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | MNH | 2014-05-14 | 209 |
14 earlier clearances. See the full list in Caduvo.
Recalls
33 product recalls in 26 recall events; 0 initiated in the last five years. Most recent: 2019-06-13.
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 Spinefrontier, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Spinefrontier, Inc.” (first 2007, latest 2020), across 10 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 Spinefrontier, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinefrontier, Inc. is 108 days.
Which FDA product codes appear under Spinefrontier, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3).
Next steps
- See all 24 Spinefrontier, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spinefrontier, Inc.'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.