The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Bioclip Craniotomy Fixation System.
| Device ID | K001530 |
| 510k Number | K001530 |
| Device Name: | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Contact | Eric V Hohenstein |
| Correspondent | Eric V Hohenstein 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 | 2000-05-17 |
| Decision Date | 2000-07-21 |