The following data is part of a premarket notification filed by Miami Device Solutions, Llc with the FDA for Mds Plating System.
Device ID | K172786 |
510k Number | K172786 |
Device Name: | MDS Plating System |
Classification | Plate, Fixation, Bone |
Applicant | Miami Device Solutions, LLC 7620 NW 25th Street, Unit 3 Miami, FL 33122 |
Contact | Michelle Montesino |
Correspondent | Michelle Montesino Miami Device Solutions, LLC 7620 NW 25th Street, Unit 3 Miami, FL 33122 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-15 |
Decision Date | 2017-12-08 |
Summary: | summary |