The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for The Bioplate Zip Craniotomy Fixation System.
| Device ID | K013050 |
| 510k Number | K013050 |
| Device Name: | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| 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 | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-11 |
| Decision Date | 2001-12-10 |
| Summary: | summary |