The following data is part of a premarket notification filed by Biomedics with the FDA for The Bioplate Rigid Fixation Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K992330 |
| 510k Number | K992330 |
| Device Name: | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOMEDICS 6911 MELROSE AVE. Los Angeles, CA 90038 |
| Contact | Eric V Hohenstein |
| Correspondent | Eric V Hohenstein BIOMEDICS 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 | 1999-07-12 |
| Decision Date | 1999-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M384P2SK06330 | K992330 | 000 |
| M3848133501 | K992330 | 000 |
| M3848133071 | K992330 | 000 |
| M3848133031 | K992330 | 000 |
| M3848131500 | K992330 | 000 |
| M3848131490 | K992330 | 000 |
| M384813148US0 | K992330 | 000 |
| M3848131480 | K992330 | 000 |
| M3848131471 | K992330 | 000 |
| M3848131460 | K992330 | 000 |
| M3848131450 | K992330 | 000 |
| M384813144US0 | K992330 | 000 |
| M3848131440 | K992330 | 000 |
| M3848133511 | K992330 | 000 |
| M3848133520 | K992330 | 000 |
| M384P2SK04230 | K992330 | 000 |
| M384P2SK0214051 | K992330 | 000 |
| M384P2SK02140 | K992330 | 000 |
| M384P2CK06320 | K992330 | 000 |
| M384P2CK04220 | K992330 | 000 |
| M3848133730 | K992330 | 000 |
| M3848133720 | K992330 | 000 |
| M3848133710 | K992330 | 000 |
| M3848133700 | K992330 | 000 |
| M3848133560 | K992330 | 000 |
| M3848133550 | K992330 | 000 |
| M3848133540 | K992330 | 000 |
| M3848131431 | K992330 | 000 |