Product code HBE
- Device name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4310
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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.U... | 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... | 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 |
| K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | 2021-04-11 |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | 2019-08-09 |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | 2019-07-19 |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | 2019-06-18 |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker | 2019-06-14 |
| K182527 | ELAN 4 Tools | Aesculap, Inc. | 2019-01-19 |
| K172709 | ELAN 4 Electro Motor System Tools | Aesculap, Inc. | 2018-10-17 |
| K182436 | POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2018-10-04 |
| K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017-09-07 |
| K162542 | OsteoMed PINNACLE Driver | Osteomed | 2017-05-19 |
| K161704 | Phasor Drill | Biotex, Inc. | 2016-12-01 |
| K153519 | DReal | Carevature Medical, Ltd. | 2016-03-16 |
| K143399 | Stryker Footed Attachments and Cutting Accessories | Stryker Corp. | 2015-05-08 |
| K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corporation | 2015-05-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630055507839 | High-Speed Micro-Motor without cable | Bien-Air Surgery SA | 2023-02-22 |
| 07630055507822 | Cable for HS-Micro-Motor,small | Bien-Air Surgery SA | 2023-02-22 |
| 07630055507815 | High-Speed Micro-Motor without cable | Bien-Air Surgery SA | 2023-02-22 |
| 07630055507792 | Cable for Perforator Motor | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506429 | HS-Handpiece,angled,150mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506412 | HS-Handpiece, angled,125mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506405 | HS-Handpiece,angled,95mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506399 | HS-Handpiece,angled,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506382 | HS-Handpiece,angled,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506375 | HS-Handpiece,straight,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055505842 | RAPIDO Micromotor | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505927 | PM2-S150 | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505910 | PM2-S125 | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505873 | Cranio Guard 15mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505866 | Cranio Guard 10mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505835 | Cranio Guard 25mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505811 | Cranio Guard 10mm rotating | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505804 | Cranio Guard 15mm rotating | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505798 | NANO Cable | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505774 | PM PERFO | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505767 | PM2-S70HD | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505750 | PM2-A70HD | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505729 | NANO Micromotor | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505712 | PM2-A125 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505705 | PM2-A95 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505699 | PM2-S70 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505682 | PM2-A150 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505675 | PM2-A70 | Bien-Air Surgery SA | 2023-02-09 |
| 07613327504019 | NA | STRYKER CORPORATION | 2021-07-08 |
| 07613327504057 | NA | STRYKER CORPORATION | 2021-07-08 |