The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Trimed Bearing Plate; Trimed Volar Bearing Plate.
| Device ID | K040112 |
| 510k Number | K040112 |
| Device Name: | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | TRI-MED, INC. 25768 PARADA DR. Valencia, CA 91355 |
| Contact | Robert J Medoff |
| Correspondent | Robert J Medoff TRI-MED, INC. 25768 PARADA DR. Valencia, 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 | 2004-01-20 |
| Decision Date | 2004-03-12 |
| Summary: | summary |