510(k) K984035
- Device
- XK-95 HIGH SPEED MOTOR DRILL SYSTEM
- Applicant
- KOMET MEDICAL
- 510(k) number
- K984035
- Product code
- HBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-03
- Date received
- 1998-11-12
- Regulation
- 882.4310
- Classification name
- Drills, Burrs, Trephines & Accessories (simple, Powered)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- COURTNEY S PARADICE
- Address
- 1679 Kellogg Springs Dr. Atlanta GA US 30338 30338
FDA Registration Numbers#
- 3030956508
- 9614948
- 3006128100
- 2029275
- 1526611
- 3028006458
- 9610612
- 3010041499
- 3014334038
- 3026776
- 1835444
- 3036773433
- 2183456
- 3002807314
- 8010177
- 8043933
- 3033509898
- 2648623
- 3005562917
- 3012607373
- 3005067367
- 3007997036
- 1047843
- 3018094310
- 3003933619
- 2011171
- 9680741
- 3009973505
- 1048735
- 8010516
- 3008868758
- 3014725904
- 2133641
- 3010097171
- 3040335671
- 3001592626
- 3010363503
- 1032347
- 1824199
- 8043792
- 1836357
- 3014479313
- 3005282635
- 1220477
- 3008812560
- 1287329
- 1045834
- 8031010
- 2025102
- 8010468
- 8044015
- 3009417901
- 3015440604
- 3005677016
- 2647346
- 1825034
- 3007031059
- 3011300255
- 2953359
- 3015453963
- 3009380063
- 8030607
- 1226544
- 3007539489
- 1649518
- 1833986
- 1828288
- 2134947
- 1220724
- 3016438694
- 3023852420
- 1045254
- 1061124
- 1526534
- 3025603301
- 3009732568
- 3015967359
- 3009970070
- 3016678045
- 3010173425
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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) | Surgify Medical OY | 2025-03-13 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases