Spine Vision, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Spine Vision, Inc.” (first 2001, latest 2005), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 6 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
Review panels
- Orthopedic (11)
- Neurology (1)
Most recent Spine Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052406 | UNI-THREAD SPINAL SYSTEM | MNI | 2005-11-07 | 67 |
| K030526 | PEDIGUARD NERVE DETECTOR SYSTEM | GWF | 2004-12-29 | 679 |
| K042930 | SPACEVISION CAGE SYSTEM | MQP | 2004-12-28 | 67 |
| K042640 | UNI-THREAD SPINAL SYSTEM | MNH | 2004-11-23 | 57 |
| K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2004-01-27 | 82 |
| K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2003-10-31 | 88 |
| K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM | MNI | 2002-09-23 | 72 |
| K021510 | UNI-T UNI-THREAD SPINAL SYSTEM | MNI | 2002-08-01 | 84 |
| K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM | KWP | 2002-08-01 | 84 |
| K013312 | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | KWP | 2002-02-13 | 132 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spine Vision, 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 Smith Partners L.P. (9 510(k)s)
- Spine View, Inc. (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 Vision, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Spine Vision, Inc.” (first 2001, latest 2005), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spine Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spine Vision, Inc. is 84 days.
Which FDA product codes appear under Spine Vision, Inc.?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 6); KWP (Appliance, Fixation, Spinal Interlaminal, 2); GWF (Stimulator, Electrical, Evoked Response, 1).
Next steps
- See all 12 Spine Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNI, Spine Vision, 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.