The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modification To Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K023810 |
| 510k Number | K023810 |
| Device Name: | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Contact | Judy Sokua |
| Correspondent | Judy Sokua BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-15 |
| Decision Date | 2002-12-04 |
| Summary: | summary |