Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4370](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4370) → HBB — Motor, Drill, Pneumatic # HBB · Motor, Drill, Pneumatic _Neurology · 21 CFR 882.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB ## Overview - **Product Code:** HBB - **Device Name:** Motor, Drill, Pneumatic - **Regulation:** [21 CFR 882.4370](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4370) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A pneumatic cranial drill motor is a pneumatically 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 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253772](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K253772.md) | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | Mar 6, 2026 | SESE | | [K172907](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K172907.md) | ELAN 4 Air Motor System | Aesculap, Inc. | Nov 9, 2018 | SESE | | [K163182](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K163182.md) | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | Medtronic Powered Surgical Solutions | Mar 23, 2017 | SESE | | [K150801](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K150801.md) | Stryker Maestro Air Motors | Stryker Corporation | May 22, 2015 | SESE | | [K101168](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K101168.md) | LEGEND POWER ADAPTER MODEL: 6475000 | Medtronic Sofamor Danek | Aug 24, 2010 | SESE | | [K093361](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K093361.md) | SYNTHES AIR PEN DRIVE (APD) SYSTEM | Synthes (Usa) | Apr 14, 2010 | SESE | | [K090112](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K090112.md) | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | Medtronic Powered Surgical Solutions | Mar 26, 2009 | SESE | | [K061297](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K061297.md) | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | Jan 26, 2007 | SESE | | [K061725](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K061725.md) | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | Oct 26, 2006 | SESE | | [K042974](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K042974.md) | MEDICON VIPAIR HIGH SPEED SYSTEM | Medicon EG | Jan 13, 2005 | SESE | | [K041754](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K041754.md) | STRYKER MAESTRO SYSTEM | Stryker Corp. | Sep 7, 2004 | SESE | | [K040186](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K040186.md) | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | Apr 15, 2004 | SESE | | [K023066](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K023066.md) | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | Nov 25, 2002 | SESE | | [K020069](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K020069.md) | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | Medtronic Midas Rex | Mar 18, 2002 | SESE | | [K013091](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K013091.md) | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Von Zeppelin GmbH | Jan 25, 2002 | SESE | | [K000195](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K000195.md) | CRANIAL DRILL | Image-Guided Neurologics, Inc. | Apr 20, 2000 | SESE | | [K993851](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K993851.md) | SODEM PERFORATOR DRIVE | Sodemsystems | Dec 27, 1999 | SESE | | [K994175](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K994175.md) | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | Sodemsystems | Dec 21, 1999 | SESE | | [K991625](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K991625.md) | KOMET XK-95 PERFORATOR MOTOR (MI-102) | Komet Medical | Jul 30, 1999 | SESE | | [K983092](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K983092.md) | TRITON HUDSON CHUCK ATTACHMENT | Mednext, Inc. | Nov 6, 1998 | SESE | ## Top Applicants - Midas Rex Pneumatic Tools, Inc. — 3 clearances - Sodemsystems — 3 clearances - The Anspach Effort, Inc. — 3 clearances - Aesculap, Inc. — 2 clearances - Medtronic Powered Surgical Solutions — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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