The following data is part of a premarket notification filed by Biomedics with the FDA for The Bioplate Fixation System.
| Device ID | K961976 |
| 510k Number | K961976 |
| Device Name: | THE BIOPLATE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOMEDICS 1920 N STREET, NW SUITE 650 Washington, DC 20036 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOMEDICS 1920 N STREET, NW SUITE 650 Washington, DC 20036 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-08-16 |
| Summary: | summary |