The following data is part of a premarket notification filed by Trilliant Surgical with the FDA for Arsenal Plating System.
Device ID | K191009 |
510k Number | K191009 |
Device Name: | Arsenal Plating System |
Classification | Plate, Fixation, Bone |
Applicant | Trilliant Surgical 727 North Shepherd Drive, Suite 100 Houston, TX 77007 |
Contact | Christopher Radzicki |
Correspondent | Christopher Radzicki Trilliant Surgical 727 North Shepherd Drive, Suite 100 Houston, TX 77007 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-16 |
Decision Date | 2019-08-12 |