FDA Product Code
FDA Product Code HBC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4360
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | 2026-09-11 | Traditional | PDF ↗ |
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-20 | Traditional | PDF ↗ |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-16 | Traditional | PDF ↗ |
| K213697 | ORiGO System | Bien-Air Surgery SA | 2022-10-31 | Traditional | PDF ↗ |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | 2022-05-19 | Traditional | PDF ↗ |
| K193630 | hekaDrill | Zethon, Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | 2019-05-12 | Traditional | PDF ↗ |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | 2018-06-22 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | 2017-03-28 | Traditional | PDF ↗ |
| K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016-07-22 | Traditional | PDF ↗ |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | The Anspach Effort, Inc. | 2014-01-10 | Special | PDF ↗ |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | 2013-12-17 | Traditional | PDF ↗ |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | Linvatec Corporation D/B/A Conmed Linvatec | 2013-03-29 | Special | PDF ↗ |
| K083112 | PRIMADO | Nakanishi, Inc. | 2009-04-29 | Traditional | PDF ↗ |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | Conmed Linvatec | 2008-04-02 | Traditional | PDF ↗ |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 | Special | PDF ↗ |
| K053526 | MICROSPEED UNI MOTOR SYSTEM | Aesculap, Inc. | 2006-01-18 | Special | PDF ↗ |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Bioplate, Inc. | 2002-11-19 | Traditional | PDF ↗ |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | Sodemsystems | 2001-10-22 | Traditional | PDF ↗ |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | 2001-10-22 | Traditional | PDF ↗ |
| K011444 | ANSPACH EMAX DRILL SYSTEM | The Anspach Effort, Inc. | 2001-08-08 | Traditional | PDF ↗ |
| K003612 | MICROSPEED EC MOTORSYSTEM GD650/GD653 | Aesculap, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K002523 | ADVANTAGE DRIVE SYSTEM | Linvatec Corp. | 2000-10-06 | Traditional | PDF ↗ |
| K972857 | SERVOTRONIC EC100 SYSTEM | Medicon EG | 1998-01-16 | Traditional | PDF ↗ |
| K862989 | SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE | Entronics | 1986-08-21 | Traditional | PDF ↗ |
| K812436 | 450/800 DRILL | Black & Decker(Tm) | 1981-11-02 | Traditional | PDF ↗ |
Product code HBC · Class II · Neurology. Data: openFDA.