The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Aset Foot Plating System.
Device ID | K192696 |
510k Number | K192696 |
Device Name: | TriMed ASET Foot Plating System |
Classification | Plate, Fixation, Bone |
Applicant | TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355 |
Contact | David Medoff |
Correspondent | David Anderson Tech2Med Ada, MI 49301 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-26 |
Decision Date | 2020-01-05 |