HBC — Motor, Drill, Electric Class II
FDA Device Classification
Classification Details
- Product Code
- HBC
- Device Class
- Class II
- Regulation Number
- 882.4360
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K233153 | saeshin precision co | Traus SSG10 Surgical System | September 20, 2024 |
| K232938 | saeshin precision co | Traus SSG30 Surgical System | September 16, 2024 |
| K213697 | bien-air surgery | ORiGO System | October 31, 2022 |
| K220485 | anspach effort | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E | May 19, 2022 |
| K193630 | zethon | hekaDrill | April 9, 2021 |
| K183515 | medtronic powered surgical solutions | MR8 Drill System, Midas Rex MR8 ClearView Tools | May 12, 2019 |
| K173066 | bien-air surgery | OSSEODUO Shaver and Drill System | June 22, 2018 |
| K170312 | medtronic powered surgical solutions | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h | May 15, 2017 |
| K163565 | medtronic powered surgical solutions | MR8 Drill System | March 28, 2017 |
| K152960 | aesculap | ELAN 4 Motor System | July 22, 2016 |
| K133604 | anspach effort | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | January 10, 2014 |
| K132264 | nakanishi | PRIMADO2 TOTAL SURGICAL SYSTEM | December 17, 2013 |
| K130497 | linvatec corporation d/b/a conmed linvatec | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | March 29, 2013 |
| K083112 | nakanishi | PRIMADO | April 29, 2009 |
| K080444 | conmed linvatec | CONMED LINVATEC OSPREY DRILL SYSTEM | April 2, 2008 |
| K060260 | linvatec | MICROPOWER HAND PIECE HIGH SPEED DRILL | April 10, 2006 |
| K053526 | aesculap | MICROSPEED UNI MOTOR SYSTEM | January 18, 2006 |
| K022986 | bioplate | THE BIOPLATE BATTERY POWERED DRILL | November 19, 2002 |
| K012453 | sodemsystems | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | October 22, 2001 |
| K012457 | sodemsystems | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | October 22, 2001 |