510(k) K250380 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
| Applicant | Surgify Medical OY, Espoo, FI |
| Decision | Substantially Equivalent, Mar 13, 2025 |
| Received | Feb 11, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.