The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K030806 |
| 510k Number | K030806 |
| Device Name: | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Contact | Carol E Jones |
| Correspondent | Carol E Jones BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-04-08 |
| Summary: | summary |