Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spineguard S.A. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
254 daysmedian FDA review time
279 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220160 | PediGuard Threaded | Spineguard S.A. | 2022-03-31 | 71 | 0 |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021-02-10 | 254 | 0 |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017-01-12 | 90 | 0 |
| K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016-06-10 | 261 | 0 |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2 | Spineguard S.A. | 2015-01-23 | 81 | 0 |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | Spineguard S.A. | 2013-08-08 | 279 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda