The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Move Forward 3d Motion Simulation Service.
Device ID | K162559 |
510k Number | K162559 |
Device Name: | Move Forward 3D Motion Simulation Service |
Classification | System, Image Processing, Radiological |
Applicant | BIOMET INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
Contact | Paul Hardy |
Correspondent | Paul Hardy BIOMET INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-14 |
Decision Date | 2017-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304992863 | K162559 | 000 |
00880304990050 | K162559 | 000 |
00880304990043 | K162559 | 000 |
00880304990036 | K162559 | 000 |
00880304990029 | K162559 | 000 |
00880304990012 | K162559 | 000 |
00880304990005 | K162559 | 000 |