The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Clavicle Fixation System.
| Device ID | K112509 |
| 510k Number | K112509 |
| Device Name: | TRIMED CLAVICLE FIXATION SYSTEM |
| 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 | 2011-08-30 |
| Decision Date | 2011-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188113932 | K112509 | 000 |
| 00842188100376 | K112509 | 000 |
| 00842188100369 | K112509 | 000 |
| 00842188100352 | K112509 | 000 |
| 00842188100345 | K112509 | 000 |
| 00842188100338 | K112509 | 000 |
| 00842188100321 | K112509 | 000 |
| 00842188100314 | K112509 | 000 |
| 00842188100307 | K112509 | 000 |
| 00842188100291 | K112509 | 000 |
| 00842188100284 | K112509 | 000 |
| 00842188100277 | K112509 | 000 |
| 00842188100260 | K112509 | 000 |
| 00842188100253 | K112509 | 000 |
| 00842188100246 | K112509 | 000 |
| 00842188124884 | K112509 | 000 |
| 00842188100383 | K112509 | 000 |
| 00842188100390 | K112509 | 000 |
| 00842188113925 | K112509 | 000 |
| 00842188113918 | K112509 | 000 |
| 00842188113901 | K112509 | 000 |
| 00842188113895 | K112509 | 000 |
| 00842188113888 | K112509 | 000 |
| 00842188113871 | K112509 | 000 |
| 00842188113864 | K112509 | 000 |
| 00842188113857 | K112509 | 000 |
| 00842188113840 | K112509 | 000 |
| 00842188113833 | K112509 | 000 |
| 00842188113826 | K112509 | 000 |
| 00842188113819 | K112509 | 000 |
| 00842188100420 | K112509 | 000 |
| 00842188100413 | K112509 | 000 |
| 00842188100406 | K112509 | 000 |
| 00842188124877 | K112509 | 000 |