The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Omnitech System & Easy Lock Osteosystem With Xtremities Plates.
Device ID | K050681 |
510k Number | K050681 |
Device Name: | OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES |
Classification | Plate, Fixation, Bone |
Applicant | TRIMED, INC. 25864 TOURNAMENT RD. SUITE E Valencia, CA 91355 |
Contact | Kelli Anderson |
Correspondent | Kelli Anderson TRIMED, INC. 25864 TOURNAMENT RD. SUITE E Valencia, CA 91355 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-16 |
Decision Date | 2005-07-27 |
Summary: | summary |