HBB — Motor, Drill, Pneumatic Class II
FDA product code HBB covers "Motor, Drill, Pneumatic", a Class II medical device regulated under 21 CFR 882.4370. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |