The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Easylock Osteosystem.
Device ID | K111266 |
510k Number | K111266 |
Device Name: | EASYLOCK OSTEOSYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | TRIMED, INC. 27533 AVENUE HOPKINS Santa Clarita, CA 91355 |
Contact | Doug Steinberger |
Correspondent | Doug Steinberger TRIMED, INC. 27533 AVENUE HOPKINS Santa Clarita, 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 | 2011-05-04 |
Decision Date | 2011-10-06 |
Summary: | summary |