The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Radiocarpal Fusion System.
| Device ID | K102785 |
| 510k Number | K102785 |
| Device Name: | TRIMED RADIOCARPAL FUSION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
| Contact | David Anderson |
| Correspondent | David 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 | 2010-09-27 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842188101342 | K102785 | 000 |
| 00842188101335 | K102785 | 000 |
| 00842188101328 | K102785 | 000 |