The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Osteotomy Plate.
| Device ID | K043263 |
| 510k Number | K043263 |
| Device Name: | TRIMED OSTEOTOMY PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
| Contact | Kelli Anderson |
| Correspondent | Kelli Anderson TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2005-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188107375 | K043263 | 000 |
| 00842188101533 | K043263 | 000 |
| 00842188107306 | K043263 | 000 |
| 00842188107313 | K043263 | 000 |
| 00842188107320 | K043263 | 000 |
| 00842188107337 | K043263 | 000 |
| 00842188107344 | K043263 | 000 |
| 00842188107351 | K043263 | 000 |
| 00842188107368 | K043263 | 000 |
| 00842188101526 | K043263 | 000 |