The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Bioplate Resorbable Bone Screw.
| Device ID | K012908 |
| 510k Number | K012908 |
| Device Name: | BIOPLATE RESORBABLE BONE SCREW |
| Classification | Screw, Fixation, Intraosseous |
| 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 | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-30 |
| Decision Date | 2001-11-28 |
| Summary: | summary |