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 |