510(k) K012457
- Device
- SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
- Applicant
- SODEM SYSTEMS
- 510(k) number
- K012457
- Product code
- HBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-22
- Date received
- 2001-08-01
- Regulation
- 882.4360
- Classification name
- Motor, Drill, Electric
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLE BURNIER
- Address
- 110 Ch. Du Pont Du Centenaire Geneva CH CH-1228 CH-1228
FDA Registration Numbers#
- 3036756245
- 3015967359
- 3018994966
- 3017210488
- 1526611
- 3014479313
- 1058584
- 3003800209
- 9610612
- 1220477
- 1422375
- 2916714
- 3002807310
- 3001239363
- 1045834
- 3025764223
- 1834331
- 3010163695
- 3002808022
- 3009417901
- 3007305485
- 3005382983
- 2648666
- 2647346
- 1625507
- 3033509898
- 1222928
- 3015453963
- 3025603301
- 1226544
- 3007456622
- 3004598644
- 3012607373
- 3007997036
- 9612501
- 3018094310
- 1649518
- 1723170
- 9680741
- 9611253
- 1048735
- 1319639
- 3016172274
- 1045254
- 1061124
- 1526534
- 3007958831
- 3009420598
- 1017294
Source Documents#
Other 510(k) Records For Product Code HBC #
| 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 |
Legacy Summary#
summary
FDA Review#
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