Cranial Drill Bits and Accessories
FDA 510(k) K170442 · Ad-Tech Medical Instrument Corporation
510(k) numberK170442
Submission
- Device name
- Cranial Drill Bits and Accessories
- Applicant
- Ad-Tech Medical Instrument Corporation
Racine, WI, US - Received
- February 14, 2017
- Decision date
- September 7, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional | Surgify Medical OY | 03/26/2026SE |
| K250815 | Hubly Drill (H100)HBE · Traditional | Hubly, Inc. | 11/06/2025SE |
| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
| K252662 | UniBurHBE · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 06/04/2025SE |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 03/13/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | Stryker Instruments | 03/11/2025SE |
| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | Biomet Microfixation | 11/15/2022SE |
More from Biomet Microfixation
| 510(k) | Device | Decision |
|---|---|---|
| K223276 | Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional | 05/18/2023SE |
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | 05/18/2023SE |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional | 01/25/2020SE |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes)GZL · Traditional | 08/09/2018SE |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional | 04/12/2017SE |
| K152769 | Fremap ElectrodeETN · Traditional | 05/06/2016SE |
| K152547 | DNAP ElectrodeGZL · Traditional | 03/04/2016SE |
| K112094 | Brain Biopsy NeedleHAW · Traditional | 04/24/2012SE |
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated | 05/30/2006SE |
| K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesGZL · Abbreviated | 05/25/2006SE |
Questions and answers
When was Cranial Drill Bits and Accessories cleared by the FDA?
Cranial Drill Bits and Accessories (K170442) received a 510(k) decision of Substantially Equivalent on September 7, 2017, 205 days after the submission was received.
What is the product code of K170442?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.