Surgify Medical Oy
Espoo Uusimaa, FI
SURGIFY MEDICAL OY appears in FDA device records in Espoo Uusimaa, FI. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Surgify Medical Oy between 2023 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253627 | 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); Surgify Halo (30.000.SEE.U2) | HBE | Substantially Equivalent | |
| K251433 | 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); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | HBE | Substantially Equivalent | |
| K250380 | 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) | HBE | Substantially Equivalent | |
| K232684 | Surgify Halo | HBE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015392173 | 3015392173 | SURGIFY MEDICAL OY | Otakaari 5 I, Espoo Uusimaa 02150 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2573-2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2572-2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2571-2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2570-2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2569-2026 | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2568-2026 | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2567-2026 | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2566-2026 | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2565-2026 | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2564-2026 | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2563-2026 | Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2562-2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2561-2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2560-2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2559-2026 | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2558-2026 | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2557-2026 | Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2556-2026 | Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified | |
| Z-2555-2026 | Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered) | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain