FDA 510(k) Applications for Medical Device Product Code "HBC"
(Motor, Drill, Electric)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K152960 | AESCULAP, INC. | ELAN 4 Motor System | 07/22/2016 |
| K003612 | AESCULAP, INC. | MICROSPEED EC MOTORSYSTEM GD650/GD653 | 02/20/2001 |
| K053526 | AESCULAP, INC. | MICROSPEED UNI MOTOR SYSTEM | 01/18/2006 |
| K213697 | Bien-Air Surgery SA | ORiGO System | 10/31/2022 |
| K173066 | Bien-Air Surgery SA | OSSEODUO Shaver and Drill System | 06/22/2018 |
| K022986 | BIOPLATE, INC. | THE BIOPLATE BATTERY POWERED DRILL | 11/19/2002 |
| K080444 | CONMED LINVATEC | CONMED LINVATEC OSPREY DRILL SYSTEM | 04/02/2008 |
| K002523 | LINVATEC CORP. | ADVANTAGE DRIVE SYSTEM | 10/06/2000 |
| K060260 | LINVATEC CORP. | MICROPOWER HAND PIECE HIGH SPEED DRILL | 04/10/2006 |
| K130497 | LINVATEC CORPORATION D/B/A CONMED LINVATEC | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | 03/29/2013 |
| K972857 | MEDICON, E.G. | SERVOTRONIC EC100 SYSTEM | 01/16/1998 |
| K170312 | MEDTRONIC POWERED SURGICAL SOLUTIONS | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | 05/15/2017 |
| K163565 | MEDTRONIC POWERED SURGICAL SOLUTIONS | MR8 Drill System | 03/28/2017 |
| K183515 | Medtronic Powered Surgical Solutions | MR8 Drill System, Midas Rex MR8 ClearView Tools | 05/12/2019 |
| K083112 | NAKANISHI, INC. | PRIMADO | 04/29/2009 |
| K132264 | NAKANISHI, INC. | PRIMADO2 TOTAL SURGICAL SYSTEM | 12/17/2013 |
| K012453 | SODEM SYSTEMS | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | 10/22/2001 |
| K012457 | SODEM SYSTEMS | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | 10/22/2001 |
| K133604 | THE ANSPACH EFFORT, INC. | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | 01/10/2014 |
| K011444 | THE ANSPACH EFFORT, INC. | ANSPACH EMAX DRILL SYSTEM | 08/08/2001 |
| K220485 | The Anspach Effort, Inc. | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | 05/19/2022 |
| K193630 | Zethon Ltd | hekaDrill | 04/09/2021 |
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