FDA 510(k) Applications for Medical Device Product Code "HBB"
(Motor, Drill, Pneumatic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K980686 | AESCULAP, INC. | AESCULAP HILAN MOTOR SYSTEM | 09/02/1998 |
| K172907 | Aesculap, Inc. | ELAN 4 Air Motor System | 11/09/2018 |
| K000195 | IMAGE-GUIDED NEUROLOGICS, INC. | CRANIAL DRILL | 04/20/2000 |
| K991625 | KOMET MEDICAL | KOMET XK-95 PERFORATOR MOTOR (MI-102) | 07/30/1999 |
| K042974 | MEDICON, E.G. | MEDICON VIPAIR HIGH SPEED SYSTEM | 01/13/2005 |
| K983092 | MEDNEXT, INC. | TRITON HUDSON CHUCK ATTACHMENT | 11/06/1998 |
| K020069 | MEDTRONIC MIDAS REX | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | 03/18/2002 |
| K163182 | Medtronic Powered Surgical Solutions | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | 03/23/2017 |
| K090112 | MEDTRONIC POWERED SURGICAL SOLUTIONS | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | 03/26/2009 |
| K101168 | MEDTRONIC SOFAMOR DANEK | LEGEND POWER ADAPTER MODEL: 6475000 | 08/24/2010 |
| K962483 | MIDAS REX PNEUMATIC TOOLS, INC. | MIDAS REX III MOTOR | 11/19/1996 |
| K972289 | MIDAS REX PNEUMATIC TOOLS, INC. | MIDAS REX MOTOR | 09/12/1997 |
| K953434 | MIDAS REX PNEUMATIC TOOLS, INC. | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) | 05/16/1996 |
| K954717 | SODEM DIFFUSION SA | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY | 01/22/1997 |
| K023066 | SODEM SYSTEMS | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | 11/25/2002 |
| K994175 | SODEM SYSTEMS | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | 12/21/1999 |
| K993851 | SODEMSYSTEMS | SODEM PERFORATOR DRIVE | 12/27/1999 |
| K041754 | STRYKER CORP. | STRYKER MAESTRO SYSTEM | 09/07/2004 |
| K150801 | STRYKER CORPORATION | Stryker Maestro Air Motors | 05/22/2015 |
| K061725 | STRYKER INSTRUMENTS | STRYKER ARIA PNEUMATIC SYSTEM | 10/26/2006 |
| K093361 | SYNTHES (USA) | SYNTHES AIR PEN DRIVE (APD) SYSTEM | 04/14/2010 |
| K061297 | THE ANSPACH EFFORT, INC. | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | 01/26/2007 |
| K040186 | THE ANSPACH EFFORT, INC. | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | 04/15/2004 |
| K960630 | THE ANSPACH EFFORT, INC. | ANSPAHC SPEED REDUCER | 11/19/1996 |
| K013091 | VON ZEPPELIN GMBH | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | 01/25/2002 |
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