Spineguard S.A.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Spineguard S.A.” (first 2013, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Since 2017 the median was 90 days, against 149 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 279 |
| 2014 | 0 | — |
| 2015 | 1 | 81 |
| 2016 | 1 | 261 |
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 254 |
| 2022 | 1 | 71 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spineguard S.A. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | 5 | 5 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
Review panels
- Neurology (6)
Most recent Spineguard S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220160 | PediGuard Threaded | PDQ | 2022-03-31 | 71 |
| K201454 | DSG Connect Technology | PDQ | 2021-02-10 | 254 |
| K162884 | SpineGuard DSG Zavation Screw System | HBG | 2017-01-12 | 90 |
| K152747 | DSG Threaded Drill System | PDQ | 2016-06-10 | 261 |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS | PDQ | 2015-01-23 | 81 |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | PDQ | 2013-08-08 | 279 |
Recalls
openFDA lists no recalls under a recalling firm named Spineguard S.A..
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.
- Spineguard (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spineguard S.A.?
FDA lists 6 510(k) clearances under the applicant name “Spineguard S.A.” (first 2013, latest 2022), 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 Spineguard S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spineguard S.A. is 172 days. Since 2017: 90 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spineguard S.A.?
The most frequent FDA product codes under this applicant name are PDQ (Neurosurgical Nerve Locator, 5); HBG (Drills, Burrs, Trephines & Accessories (Manual), 1).
Next steps
- See all 6 Spineguard S.A. clearances with predicates and recalls
- Run predicate analysis for product code PDQ, Spineguard S.A.'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.