The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modified Screw Designs For Use With The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K022890 |
| 510k Number | K022890 |
| Device Name: | MODIFIED SCREW DESIGNS FOR USE WITH 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-30 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848120650 | K022890 | 000 |
| M3848120721 | K022890 | 000 |
| M384812072US1 | K022890 | 000 |
| M3848120731 | K022890 | 000 |
| M384812073US1 | K022890 | 000 |
| M3848120751 | K022890 | 000 |
| M384812075US1 | K022890 | 000 |
| M3848120761 | K022890 | 000 |
| M384812076US1 | K022890 | 000 |
| M3848120771 | K022890 | 000 |
| M384812077US1 | K022890 | 000 |
| M3848120781 | K022890 | 000 |
| M384812078US1 | K022890 | 000 |
| M3848120791 | K022890 | 000 |
| M3848120801 | K022890 | 000 |
| M384812080US1 | K022890 | 000 |
| M3848133011 | K022890 | 000 |
| M384812071US1 | K022890 | 000 |
| M3848120711 | K022890 | 000 |
| M384812070US0 | K022890 | 000 |
| M384812065CP1 | K022890 | 000 |
| M384812065US0 | K022890 | 000 |
| M3848120660 | K022890 | 000 |
| M384812066CP1 | K022890 | 000 |
| M384812066US0 | K022890 | 000 |
| M3848120670 | K022890 | 000 |
| M384812067CP1 | K022890 | 000 |
| M384812067US0 | K022890 | 000 |
| M3848120680 | K022890 | 000 |
| M384812068CP1 | K022890 | 000 |
| M384812068US0 | K022890 | 000 |
| M3848120690 | K022890 | 000 |
| M384812069CP1 | K022890 | 000 |
| M384812069US0 | K022890 | 000 |
| M3848120700 | K022890 | 000 |
| M384812070CP1 | K022890 | 000 |
| M384SCD203010 | K022890 | 000 |
| M384SCD203051 | K022890 | 000 |
| M384SCD20305US1 | K022890 | 000 |
| M384SCD30405US1 | K022890 | 000 |
| M384SCD304101 | K022890 | 000 |
| M384SCD304501 | K022890 | 000 |
| M384SCD305010 | K022890 | 000 |
| M384SCD305051 | K022890 | 000 |
| M384SCD30505US1 | K022890 | 000 |
| M384SCD306010 | K022890 | 000 |
| M384SCD306051 | K022890 | 000 |
| M384SCD30605US1 | K022890 | 000 |
| M384SCD803010 | K022890 | 000 |
| M384SCD803051 | K022890 | 000 |
| M384SCD804010 | K022890 | 000 |
| M384SCD804051 | K022890 | 000 |
| M384SCD805010 | K022890 | 000 |
| M384SCD805051 | K022890 | 000 |
| M384SCP412051 | K022890 | 000 |
| M384SCD304051 | K022890 | 000 |
| M384SCD304010 | K022890 | 000 |
| M384SCD303501 | K022890 | 000 |
| M384SCD20350US1 | K022890 | 000 |
| M384SCD204010 | K022890 | 000 |
| M384SCD204051 | K022890 | 000 |
| M384SCD20405US1 | K022890 | 000 |
| M384SCD204101 | K022890 | 000 |
| M384SCD204501 | K022890 | 000 |
| M384SCD20450US1 | K022890 | 000 |
| M384SCD205010 | K022890 | 000 |
| M384SCD205051 | K022890 | 000 |
| M384SCD20505US1 | K022890 | 000 |
| M384SCD205501 | K022890 | 000 |
| M384SCD206010 | K022890 | 000 |
| M384SCD206051 | K022890 | 000 |
| M384SCD303010 | K022890 | 000 |
| M384SCD303051 | K022890 | 000 |
| M384SCD30305US1 | K022890 | 000 |
| M3848120811 | K022890 | 000 |