The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Eos Small Bone Fixation System.
| Device ID | K112794 |
| 510k Number | K112794 |
| Device Name: | EOS SMALL BONE 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 |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2012-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188119668 | K112794 | 000 |
| 00842188108891 | K112794 | 000 |
| 00842188108884 | K112794 | 000 |
| 00842188108877 | K112794 | 000 |
| 00842188107290 | K112794 | 000 |
| 00842188107283 | K112794 | 000 |
| 00842188107276 | K112794 | 000 |
| 00842188107269 | K112794 | 000 |
| 00842188107252 | K112794 | 000 |
| 00842188107245 | K112794 | 000 |
| 00842188107238 | K112794 | 000 |
| 00842188107221 | K112794 | 000 |
| 00842188107214 | K112794 | 000 |
| 00842188107207 | K112794 | 000 |
| 00842188107191 | K112794 | 000 |
| 00842188107184 | K112794 | 000 |
| 00842188107177 | K112794 | 000 |
| 00842188107160 | K112794 | 000 |
| 00842188108907 | K112794 | 000 |
| 00842188108914 | K112794 | 000 |
| 00842188119651 | K112794 | 000 |
| 00842188119644 | K112794 | 000 |
| 00842188119637 | K112794 | 000 |
| 00842188119620 | K112794 | 000 |
| 00842188119613 | K112794 | 000 |
| 00842188109034 | K112794 | 000 |
| 00842188109027 | K112794 | 000 |
| 00842188109010 | K112794 | 000 |
| 00842188109003 | K112794 | 000 |
| 00842188108990 | K112794 | 000 |
| 00842188108983 | K112794 | 000 |
| 00842188108976 | K112794 | 000 |
| 00842188108969 | K112794 | 000 |
| 00842188108952 | K112794 | 000 |
| 00842188108945 | K112794 | 000 |
| 00842188108938 | K112794 | 000 |
| 00842188108921 | K112794 | 000 |
| 00842188107153 | K112794 | 000 |