HBB — Motor, Drill, Pneumatic Class II
FDA Device Classification
Classification Details
- Product Code
- HBB
- Device Class
- Class II
- Regulation Number
- 882.4370
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K253772 | adeor medical | Velocity Alpha MR High Speed Surgical Drill System | March 6, 2026 |
| K172907 | aesculap | ELAN 4 Air Motor System | November 9, 2018 |
| K163182 | medtronic powered surgical solutions | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo | March 23, 2017 |
| K150801 | stryker corporation | Stryker Maestro Air Motors | May 22, 2015 |
| K101168 | medtronic sofamor danek | LEGEND POWER ADAPTER MODEL: 6475000 | August 24, 2010 |
| K093361 | synthes (usa) | SYNTHES AIR PEN DRIVE (APD) SYSTEM | April 14, 2010 |
| K090112 | medtronic powered surgical solutions | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC | March 26, 2009 |
| K061297 | anspach effort | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | January 26, 2007 |
| K061725 | stryker instruments | STRYKER ARIA PNEUMATIC SYSTEM | October 26, 2006 |
| K042974 | medicon eg | MEDICON VIPAIR HIGH SPEED SYSTEM | January 13, 2005 |
| K041754 | stryker | STRYKER MAESTRO SYSTEM | September 7, 2004 |
| K040186 | anspach effort | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | April 15, 2004 |
| K023066 | sodemsystems | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | November 25, 2002 |
| K020069 | medtronic midas rex | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM O | March 18, 2002 |
| K013091 | von zeppelin | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | January 25, 2002 |
| K000195 | image-guided neurologics | CRANIAL DRILL | April 20, 2000 |
| K993851 | sodemsystems | SODEM PERFORATOR DRIVE | December 27, 1999 |
| K994175 | sodemsystems | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | December 21, 1999 |
| K991625 | komet medical | KOMET XK-95 PERFORATOR MOTOR (MI-102) | July 30, 1999 |
| K983092 | mednext | TRITON HUDSON CHUCK ATTACHMENT | November 6, 1998 |