The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Omnitech Large, Trimed Compression Screw.
Device ID | K093676 |
510k Number | K093676 |
Device Name: | OMNITECH LARGE, TRIMED COMPRESSION SCREW |
Classification | Screw, Fixation, Bone |
Applicant | TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
Contact | Kelli Anderson |
Correspondent | Kelli Anderson TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-27 |
Decision Date | 2010-03-17 |
Summary: | summary |