Product code HBC
- Device name
- Motor, Drill, Electric
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4360
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-20 |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-16 |
| K213697 | ORiGO System | Bien-Air Surgery SA | 2022-10-31 |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | 2022-05-19 |
| K193630 | hekaDrill | Zethon, Ltd. | 2021-04-09 |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019-05-12 |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018-06-22 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | Medtronic Powered Surgical Solutions | 2017-05-15 |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017-03-28 |
| K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016-07-22 |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | The Anspach Effort, Inc. | 2014-01-10 |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | 2013-12-17 |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | 2013-03-29 |
| K083112 | PRIMADO | Nakanishi, Inc. | 2009-04-29 |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | Conmed Linvatec | 2008-04-02 |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 |
| K053526 | MICROSPEED UNI MOTOR SYSTEM | Aesculap, Inc. | 2006-01-18 |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Bioplate, Inc. | 2002-11-19 |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | Sodemsystems | 2001-10-22 |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | 2001-10-22 |
| K011444 | ANSPACH EMAX DRILL SYSTEM | The Anspach Effort, Inc. | 2001-08-08 |
| K003612 | MICROSPEED EC MOTORSYSTEM GD650/GD653 | Aesculap, Inc. | 2001-02-20 |
| K002523 | ADVANTAGE DRIVE SYSTEM | Linvatec Corp. | 2000-10-06 |
| K972857 | SERVOTRONIC EC100 SYSTEM | Medicon EG | 1998-01-16 |
| K862989 | SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE | Entronics | 1986-08-21 |
| K812436 | 450/800 DRILL | Black & Decker(Tm) | 1981-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630055506405 | HS-Handpiece,angled,95mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506399 | HS-Handpiece,angled,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506382 | HS-Handpiece,angled,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055506375 | HS-Handpiece,straight,70mm,80k | Bien-Air Surgery SA | 2023-02-22 |
| 07630055505927 | PM2-S150 | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505910 | PM2-S125 | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505873 | Cranio Guard 15mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505866 | Cranio Guard 10mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505842 | RAPIDO Micromotor | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505835 | Cranio Guard 25mm fix | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505811 | Cranio Guard 10mm rotating | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505804 | Cranio Guard 15mm rotating | Bien-Air Surgery SA | 2023-02-10 |
| 07630055505767 | PM2-S70HD | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505798 | NANO Cable | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505774 | PM PERFO | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505750 | PM2-A70HD | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505729 | NANO Micromotor | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505712 | PM2-A125 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505705 | PM2-A95 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505699 | PM2-S70 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505682 | PM2-A150 | Bien-Air Surgery SA | 2023-02-09 |
| 07630055505675 | PM2-A70 | Bien-Air Surgery SA | 2023-02-09 |
| ENOU18739 | Clip for Motor cable | Nouvag AG | 2018-08-21 |
| ENOU33910 | HighSurg 11 | Nouvag AG | 2018-08-21 |
| ENOU33650 | HighSurg 30 | Nouvag AG | 2018-08-21 |
| ENOU19849 | NOU-CLEAN SPRAY | Nouvag AG | 2018-08-15 |
| ENOU60259 | Tubing set | Nouvag AG | 2017-01-16 |
| ENOU60249 | Tubing set | Nouvag AG | 2017-01-16 |
| ENOU2099NOU0 | Electronic motor 21 | Nouvag AG | 2017-01-13 |
| ENOU2098NOU0 | Electronic motor 21 | Nouvag AG | 2017-01-13 |