The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Humeral Supracondylar Fixation System.
| Device ID | K151735 |
| 510k Number | K151735 |
| Device Name: | TriMed Humeral Supracondylar Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355 |
| Contact | Michael Capellan |
| Correspondent | Michael Capellan 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 | 2015-06-26 |
| Decision Date | 2016-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188115301 | K151735 | 000 |
| 00842188115103 | K151735 | 000 |
| 00842188115097 | K151735 | 000 |
| 00842188115080 | K151735 | 000 |
| 00842188115073 | K151735 | 000 |
| 00842188115066 | K151735 | 000 |
| 00842188115059 | K151735 | 000 |
| 00842188115042 | K151735 | 000 |
| 00842188115035 | K151735 | 000 |
| 00842188115028 | K151735 | 000 |
| 00842188115011 | K151735 | 000 |
| 00842188115004 | K151735 | 000 |
| 00842188114991 | K151735 | 000 |
| 00842188114984 | K151735 | 000 |
| 00842188114977 | K151735 | 000 |
| 00842188119804 | K151735 | 000 |
| 00842188119798 | K151735 | 000 |
| 00842188119828 | K151735 | 000 |
| 00842188115110 | K151735 | 000 |
| 00842188115127 | K151735 | 000 |
| 00842188115295 | K151735 | 000 |
| 00842188115288 | K151735 | 000 |
| 00842188115271 | K151735 | 000 |
| 00842188115264 | K151735 | 000 |
| 00842188115257 | K151735 | 000 |
| 00842188115240 | K151735 | 000 |
| 00842188115233 | K151735 | 000 |
| 00842188115226 | K151735 | 000 |
| 00842188115219 | K151735 | 000 |
| 00842188115202 | K151735 | 000 |
| 00842188115196 | K151735 | 000 |
| 00842188115189 | K151735 | 000 |
| 00842188115172 | K151735 | 000 |
| 00842188115165 | K151735 | 000 |
| 00842188115158 | K151735 | 000 |
| 00842188115141 | K151735 | 000 |
| 00842188115134 | K151735 | 000 |
| 00842188119811 | K151735 | 000 |