Spinalight, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Spinalight, Inc.” (first 1994, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 172 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 | 1 | 302 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 Spinalight, Inc. took a median 302 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LXM | Manipulator, Plunger-Like Joint | 4 | 4 |
| INQ | Table, Powered | 2 | 2 |
| JFB | Table, Physical Therapy, Multi Function | 1 | 1 |
Review panels
Most recent Spinalight, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172536 | Atlas Percussion Adjusting Instrument | LXM | 2018-06-20 | 302 |
| K001476 | TORQUE INSTRUMENT, MODEL 8500 | LXM | 2000-08-04 | 85 |
| K955540 | HAND HELD ATLAS INSTRUMENT | LXM | 1996-03-04 | 90 |
| K946258 | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT | LXM | 1995-11-20 | 349 |
| K945954 | MODELS 4100 AND 4300 MULTITHERAPY | JFB | 1995-01-19 | 44 |
| K933622 | FLEXION DISTRACTION TABLE | INQ | 1994-01-07 | 172 |
| K933621 | HILO TABLE | INQ | 1994-01-07 | 172 |
Recalls
openFDA lists no recalls under a recalling firm named Spinalight, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spinalight, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Spinalight, Inc.” (first 1994, latest 2018), across 3 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 Spinalight, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinalight, Inc. is 172 days.
Which FDA product codes appear under Spinalight, Inc.?
The most frequent FDA product codes under this applicant name are LXM (Manipulator, Plunger-Like Joint, 4); INQ (Table, Powered, 2); JFB (Table, Physical Therapy, Multi Function, 1).
Next steps
- See all 7 Spinalight, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXM, Spinalight, 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 (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.