Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list SpineGuard with 7 510(k) clearances. The most recent is a 510(k) clearance dated Sep 26, 2024: Cannulated PsiFGuard.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 26, 2024 | Cannulated PsiFGuardK241895 · SCY | 510(k) clearances |
| Mar 31, 2022 | PediGuard ThreadedK220160 · PDQ | 510(k) clearances |
| Feb 10, 2021 | DSG Connect TechnologyK201454 · PDQ | 510(k) clearances |
| Jan 12, 2017 | SpineGuard DSG Zavation Screw SystemK162884 · HBG | 510(k) clearances |
| Jun 10, 2016 | DSG Threaded Drill SystemK152747 · PDQ | 510(k) clearances |
| Jan 23, 2015 | 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 XSK143159 · PDQ | 510(k) clearances |
| Aug 8, 2013 | PEDIGUARD NERVE DETECTOR SYSTEMK123390 · PDQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
