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 |