510(k) K250380
- Device
- 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
- 510(k) number
- K250380
- Product code
- HBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-13
- Date received
- 2025-02-11
- Regulation
- 882.4310
- Classification name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jukka Kreander
- Address
- Otakaari 5 Espoo FI 02150 02150
FDA Registration Numbers
- 3036773433
- 1450662
- 3010591625
- 2650143
- 1061124
- 3001592626
- 3004464325
- 3014252644
- 3001239363
- 3015453963
- 2183744
- 3003933619
- 3023852420
- 1834331
- 1824199
- 3015212339
- 8044015
- 9681479
- 3038472982
- 3025603301
- 3010163695
- 1045834
- 3034676720
- 2025102
- 3013557562
- 9610612
- 2246552
- 2027754
- 3015882686
- 3017521423
- 3028006458
- 1625507
- 3029300352
- 3017210488
- 3002807314
- 1045254
- 2916714
- 3007031059
- 8010177
- 3005382983
- 3003800209
- 3030733800
- 3016172274
- 9614948
- 3016438694
- 1287329
- 3009973336
- 3010097171
- 3006128100
- 3002808022
- 9680741
- 8043933
- 1649518
- 1058584
- 1030489
- 2953359
- 1526611
- 3015151147
- 3005562917
- 3005282635
- 3002807310
- 3010041499
- 1723170
- 3009417901
- 8031010
- 3009732568
- 1526534
- 1828288
- 3008812560
- 1835251
- 2133641
- 3003120897
- 1825034
- 2647346
- 2648623
- 3021632375
- 3007997036
- 3040335671
- 2134947
- 9611253
- 3030446844
- 3014334038
- 1720929
- 3012494290
- 3010659131
- 3009973505
- 8030965
- 9612501
- 1422375
- 1220477
- 1047843
- 3006017180
- 1835444
- 3009380063
- 3016577622
- 1032347
- 3014725904
- 2029275
- 3025764223
- 1226544
- 1836161
- 3012607373
- 1048735
- 3005067367
- 3008868758
- 3015392173
- 3005677016
- 1833986
- 8010516
- 3033509898
- 3010173425
- 3015440604
- 2183456
- 3026776
- 3015399803
- 3036756245
- 8031020
- 3010375018
- 3014479313
- 3016678045
- 3002806603
- 3005706667
- 3011577940
- 8030607
- 3007539489
- 1220724
- 3010155648
- 8010468
- 9616696
- 3015967359
- 3030956508
- 8043792
- 2011171
- 3010363503
- 1836357
- 3018094310
- 3003418325
- 2648666
- 3011300255
Source Documents
Other 510(k) Records For Product Code HBE
| 510(k) | Device | Applicant | 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) | Surgify Medical OY | 2026-03-26 |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025-11-06 |
| K252060 | GREEN | Phasor Health, LLC | 2025-10-31 |
| K252662 | UniBur | Nakanishi, Inc. | 2025-09-19 |
| 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) | Surgify Medical OY | 2025-06-04 |
| K250374 | 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 | Stryker Instruments | 2025-03-11 |
| K232684 | Surgify Halo | Surgify Medical OY | 2023-11-29 |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023-05-04 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022-11-15 |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022-08-23 |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 |
| K213454 | 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 | Medtronic Powered Surgical Solutions | 2021-11-23 |
| K202120 | P300 Attachment | Nakanishi, Inc. | 2021-10-22 |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | 2021-08-24 |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021-06-30 |