Spine View, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Spine View, Inc.” (first 2008, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 115 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 | 4 | 100 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 150 |
| 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 |
|---|---|---|---|
| HRX | Arthroscope | 7 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
Review panels
- Orthopedic (9)
Most recent Spine View, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160856 | SpineView X-Pac Expandable Lumbar Cage System | MAX | 2016-08-01 | 126 |
| K152539 | SpineView X-Pac Expandable Lumbar Cage System | MAX | 2016-02-24 | 173 |
| K122134 | FLEXLITE CAMERA | HRX | 2012-12-27 | 162 |
| K121548 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | HRX | 2012-08-16 | 83 |
| K120680 | ENSPIRE DISCECTOMY SYSTEM | HRX | 2012-06-26 | 112 |
| K113362 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | HRX | 2012-02-10 | 87 |
| K110992 | ENSPIRE DEBRIDER SYSTEM | HRX | 2011-10-21 | 196 |
| K090278 | ENSPIRE DEBRIDER SYSTEM | HRX | 2009-04-15 | 70 |
| K081051 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | HRX | 2008-08-07 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Spine View, Inc..
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.
- Spine Wave, Inc. (59 510(k)s)
- Spine Vision, Inc. (12 510(k)s)
- Spine Smith Partners L.P. (9 510(k)s)
- Spine Next America (5 510(k)s)
- Spine Next SA (3 510(k)s)
- Spine Smith Holdings, LLC (3 510(k)s)
- Spine Innovation, LLC (2 510(k)s)
- Spine Works (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spine View, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Spine View, Inc.” (first 2008, latest 2016), across 2 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 Spine View, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spine View, Inc. is 115 days.
Which FDA product codes appear under Spine View, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 7); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 9 Spine View, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Spine View, 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.