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 |