510(k) K253627 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2);
| Applicant | Surgify Medical OY, Espoo, FI |
| Decision | Substantially Equivalent, Mar 26, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) Open, Classified |
HBE | None listed |
| Jun 24, 2026 | SURGIFY MEDICAL OY Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; 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.U1; 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.U1; 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: 54.125.NVG.U1; 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.U1; 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.