The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Sterile Plate & Screw Kit Configurations For Use With The Bioplate Titanium Fixation System.
| Device ID | K022033 |
| 510k Number | K022033 |
| Device Name: | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOPLATE, INC. 815 CONNECTICUT AVE NW Washington, DC 20006 -4004 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOPLATE, INC. 815 CONNECTICUT AVE NW Washington, DC 20006 -4004 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-07-19 |
| Summary: | summary |