The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Mr8 Drill System.
Device ID | K163565 |
510k Number | K163565 |
Device Name: | MR8 Drill System |
Classification | Motor, Drill, Electric |
Applicant | MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
Contact | Deep Pal |
Correspondent | John Connor MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville, CO 80027 |
Product Code | HBC |
Subsequent Product Code | ERL |
Subsequent Product Code | HBB |
Subsequent Product Code | HBE |
Subsequent Product Code | HSZ |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-19 |
Decision Date | 2017-03-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169912137 | K163565 | 000 |