The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K021684 |
| 510k Number | K021684 |
| Device Name: | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Contact | Carol E Jones |
| Correspondent | Carol E Jones BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M384815771US0 | K021684 | 000 |
| M3848135281 | K021684 | 000 |
| M384813528US1 | K021684 | 000 |
| M3848157680 | K021684 | 000 |
| M3848157690 | K021684 | 000 |
| M3848157700 | K021684 | 000 |
| M384815770CP1 | K021684 | 000 |
| M384815770US0 | K021684 | 000 |
| M3848157710 | K021684 | 000 |
| M384815771CP1 | K021684 | 000 |
| M3848134880 | K021684 | 000 |