Atlas FDA

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)

FDA 510(k) clearance K250380 · decided 2025-03-13

Clearance details

K-number
K250380
Device name
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
Decision
Substantially Equivalent
Date received
2025-02-11
Decision date
2025-03-13
Days to decision
30 days
Clearance type
Special
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Espoo, FI
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K253627)Surgify Medical OY2026-03-26
Hubly Drill (H100) (K250815)Hubly, Inc.2025-11-06
GREEN (K252060)Phasor Health, LLC2025-10-31
UniBur (K252662)Nakanishi, Inc.2025-09-19
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) (K251433)Surgify Medical OY2025-06-04
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (K250374)Stryker Instruments2025-03-11
Surgify Halo (K232684)Surgify Medical OY2023-11-29
Hubly Electric Drill (H100) (K230619)Hubly, Inc.2023-05-04
2.1 x 255mm Drill, 22mm Stop (K223199)Biomet Microfixation2022-11-15
2.1 x 255mm Drill, 22mm Stop (K213072)Biomet Micofixation2022-08-23
Twist Drills (K213208)Biomet Microfixation2021-12-23
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm (K213454)Medtronic Powered Surgical Solutions2021-11-23

Recalls involving this device

RecordFirmDate
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trep recall (Z-2564-2026)SURGIFY MEDICAL OY2026-06-24
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines recall (Z-2566-2026)SURGIFY MEDICAL OY2026-06-24
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & acce recall (Z-2568-2026)SURGIFY MEDICAL OY2026-06-24
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines recall (Z-2570-2026)SURGIFY MEDICAL OY2026-06-24
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines recall (Z-2572-2026)SURGIFY MEDICAL OY2026-06-24