HBB · Motor, Drill, Pneumatic
Neurology · 21 CFR 882.4370 · Class 2
Overview
| Product Code | HBB |
|---|---|
| Device Name | Motor, Drill, Pneumatic |
| Regulation | 21 CFR 882.4370 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | Mar 6, 2026 | SESE |
| K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | Nov 9, 2018 | SESE |
| K163182 | 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 | Stryker Maestro Air Motors | Stryker Corporation | May 22, 2015 | SESE |
| K101168 | LEGEND POWER ADAPTER MODEL: 6475000 | Medtronic Sofamor Danek | Aug 24, 2010 | SESE |
| K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | Synthes (Usa) | Apr 14, 2010 | SESE |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | Medtronic Powered Surgical Solutions | Mar 26, 2009 | SESE |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | Jan 26, 2007 | SESE |
| K061725 | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | Oct 26, 2006 | SESE |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Medicon EG | Jan 13, 2005 | SESE |
| K041754 | STRYKER MAESTRO SYSTEM | Stryker Corp. | Sep 7, 2004 | SESE |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | Apr 15, 2004 | SESE |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | Nov 25, 2002 | SESE |
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | Medtronic Midas Rex | Mar 18, 2002 | SESE |
| K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Von Zeppelin GmbH | Jan 25, 2002 | SESE |
| K000195 | CRANIAL DRILL | Image-Guided Neurologics, Inc. | Apr 20, 2000 | SESE |
| K993851 | SODEM PERFORATOR DRIVE | Sodemsystems | Dec 27, 1999 | SESE |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | Sodemsystems | Dec 21, 1999 | SESE |
| K991625 | KOMET XK-95 PERFORATOR MOTOR (MI-102) | Komet Medical | Jul 30, 1999 | SESE |
| K983092 | 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
