FDA Product Code
FDA Product Code HBB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4370
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | 2026-03-06 | Traditional | PDF ↗ |
| K172907 | ELAN 4 Air Motor System | Aesculap, Inc. | 2018-11-09 | Traditional | PDF ↗ |
| 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 | 2017-03-23 | Traditional | PDF ↗ |
| K150801 | Stryker Maestro Air Motors | Stryker Corporation | 2015-05-22 | Special | PDF ↗ |
| K101168 | LEGEND POWER ADAPTER MODEL: 6475000 | Medtronic Sofamor Danek | 2010-08-24 | Traditional | PDF ↗ |
| K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM | Synthes (Usa) | 2010-04-14 | Traditional | PDF ↗ |
| K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 | Medtronic Powered Surgical Solutions | 2009-03-26 | Traditional | PDF ↗ |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K061725 | STRYKER ARIA PNEUMATIC SYSTEM | Stryker Instruments | 2006-10-26 | Traditional | PDF ↗ |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Medicon EG | 2005-01-13 | Traditional | PDF ↗ |
| K041754 | STRYKER MAESTRO SYSTEM | Stryker Corp. | 2004-09-07 | Traditional | PDF ↗ |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | The Anspach Effort, Inc. | 2004-04-15 | Traditional | PDF ↗ |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | 2002-11-25 | Traditional | PDF ↗ |
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | Medtronic Midas Rex | 2002-03-18 | Traditional | PDF ↗ |
| K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Von Zeppelin GmbH | 2002-01-25 | Traditional | PDF ↗ |
| K000195 | CRANIAL DRILL | Image-Guided Neurologics, Inc. | 2000-04-20 | Traditional | PDF ↗ |
| K993851 | SODEM PERFORATOR DRIVE | Sodemsystems | 1999-12-27 | Traditional | PDF ↗ |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | Sodemsystems | 1999-12-21 | Special | PDF ↗ |
| K991625 | KOMET XK-95 PERFORATOR MOTOR (MI-102) | Komet Medical | 1999-07-30 | Traditional | PDF ↗ |
| K983092 | TRITON HUDSON CHUCK ATTACHMENT | Mednext, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K980686 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K972289 | MIDAS REX MOTOR | Midas Rex Pneumatic Tools, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K954717 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY | Sodem Diffusion SA | 1997-01-22 | Traditional | PDF ↗ |
| K960630 | ANSPAHC SPEED REDUCER | The Anspach Effort, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K962483 | MIDAS REX III MOTOR | Midas Rex Pneumatic Tools, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K953434 | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) | Midas Rex Pneumatic Tools, Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K895739 | MICROMEDICS SURGICAL DRILL SYSTEM | Micromedics, Inc. | 1989-10-13 | Traditional | PDF ↗ |
Product code HBB · Class II · Neurology. Data: openFDA.