Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4360](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4360) → HBC — Motor, Drill, Electric # HBC · Motor, Drill, Electric _Neurology · 21 CFR 882.4360 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC ## Overview - **Product Code:** HBC - **Device Name:** Motor, Drill, Electric - **Regulation:** [21 CFR 882.4360](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4360) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233153](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K233153.md) | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | Sep 20, 2024 | SESE | | [K232938](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K232938.md) | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | Sep 16, 2024 | SESE | | [K213697](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K213697.md) | ORiGO System | Bien-Air Surgery SA | Oct 31, 2022 | SESE | | [K220485](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K220485.md) | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | May 19, 2022 | SESE | | [K193630](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K193630.md) | hekaDrill | Zethon, Ltd. | Apr 9, 2021 | SESE | | [K183515](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K183515.md) | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | May 12, 2019 | SESE | | [K173066](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K173066.md) | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | Jun 22, 2018 | SESE | | [K170312](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K170312.md) | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | Medtronic Powered Surgical Solutions | May 15, 2017 | SESE | | [K163565](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K163565.md) | MR8 Drill System | Medtronic Powered Surgical Solutions | Mar 28, 2017 | SESE | | [K152960](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K152960.md) | ELAN 4 Motor System | Aesculap, Inc. | Jul 22, 2016 | SESE | | [K133604](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K133604.md) | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | The Anspach Effort, Inc. | Jan 10, 2014 | SESE | | [K132264](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K132264.md) | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | Dec 17, 2013 | SESE | | [K130497](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K130497.md) | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | Mar 29, 2013 | SESE | | [K083112](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K083112.md) | PRIMADO | Nakanishi, Inc. | Apr 29, 2009 | SESE | | [K080444](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K080444.md) | CONMED LINVATEC OSPREY DRILL SYSTEM | Conmed Linvatec | Apr 2, 2008 | SESE | | [K060260](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K060260.md) | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | Apr 10, 2006 | SESE | | [K053526](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K053526.md) | MICROSPEED UNI MOTOR SYSTEM | Aesculap, Inc. | Jan 18, 2006 | SESE | | [K022986](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K022986.md) | THE BIOPLATE BATTERY POWERED DRILL | Bioplate, Inc. | Nov 19, 2002 | SESE | | [K012457](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K012457.md) | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | Oct 22, 2001 | SESE | | [K012453](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC/K012453.md) | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | Sodemsystems | Oct 22, 2001 | SESE | ## Top Applicants - Aesculap, Inc. — 3 clearances - Medtronic Powered Surgical Solutions — 3 clearances - The Anspach Effort, Inc. — 3 clearances - Bien-Air Surgery SA — 2 clearances - Linvatec Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com