The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Mandible Fixation System.
| Device ID | K012910 |
| 510k Number | K012910 |
| Device Name: | THE BIOPLATE MANDIBLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 1666 K ST. NW SUITE 200 Washington, DC 20006 -4004 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOPLATE, INC. 1666 K ST. NW SUITE 200 Washington, DC 20006 -4004 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-30 |
| Decision Date | 2001-11-20 |