The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Ipc Systems, Legend Ehs Handpieces And Legend Stylus Touch Handpiece, Microsaw Handpieces,triton Electric High Torque Handpiece, Attachments And Surgical Dissecting Tools.
Device ID | K170312 |
510k Number | K170312 |
Device Name: | IPC Systems, Legend EHS Handpieces And Legend Stylus Touch Handpiece, Microsaw Handpieces,Triton Electric High Torque Handpiece, Attachments And Surgical Dissecting Tools |
Classification | Motor, Drill, Electric |
Applicant | MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST Fort Worth, TX 76137 |
Contact | Deep Pal |
Correspondent | Xiaojian Sun MEDTRONIC NEUROSURGERY 125 CREMONA DR Goleta, CA 93117 |
Product Code | HBC |
Subsequent Product Code | EQJ |
Subsequent Product Code | ERL |
Subsequent Product Code | HBE |
Subsequent Product Code | HRX |
Subsequent Product Code | HWE |
Subsequent Product Code | KFK |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-01 |
Decision Date | 2017-05-15 |
Summary: | summary |