The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Threaded Intramedullary Nail System.
Device ID | K211783 |
510k Number | K211783 |
Device Name: | TriMed Threaded Intramedullary Nail System |
Classification | Screw, Fixation, Bone |
Applicant | TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355 |
Contact | David Medoff |
Correspondent | David Anderson Tech2Med, LLC 6450 Old Darby TRL NE Ada, MI 49301 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-09 |
Decision Date | 2021-08-06 |