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 | K972463 |
| 510k Number | K972463 |
| Device Name: | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
| Classification | Plate, Bone |
| Applicant | BIOMEDICS 536 SOUTH RIMPAU BLVD. Los Angeles, CA 90020 |
| Contact | Carol E Jones |
| Correspondent | Carol E Jones BIOMEDICS 536 SOUTH RIMPAU BLVD. Los Angeles, CA 90020 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848133570 | K972463 | 000 |
| M384815743US0 | K972463 | 000 |
| M3848157440 | K972463 | 000 |
| M384815744CP1 | K972463 | 000 |
| M384815744US0 | K972463 | 000 |
| M3848157450 | K972463 | 000 |
| M384815745CP1 | K972463 | 000 |
| M384815745US0 | K972463 | 000 |
| M3848157461 | K972463 | 000 |
| M384815746US1 | K972463 | 000 |
| M384SCR803010 | K972463 | 000 |
| M384SCR804010 | K972463 | 000 |
| M384SCR805010 | K972463 | 000 |
| M384815743CP1 | K972463 | 000 |
| M3848157430 | K972463 | 000 |
| M384815742US1 | K972463 | 000 |
| M3848133581 | K972463 | 000 |
| M384813358US1 | K972463 | 000 |
| M3848133591 | K972463 | 000 |
| M3848135211 | K972463 | 000 |
| M384813521US1 | K972463 | 000 |
| M3848135291 | K972463 | 000 |
| M384813529US1 | K972463 | 000 |
| M3848157401 | K972463 | 000 |
| M384815740US1 | K972463 | 000 |
| M3848157411 | K972463 | 000 |
| M384815741US1 | K972463 | 000 |
| M3848157421 | K972463 | 000 |
| M384SCR806010 | K972463 | 000 |
| M384SCR808010 | K972463 | 000 |
| M384813029US0 | K972463 | 000 |
| M3848130300 | K972463 | 000 |
| M384813030CP1 | K972463 | 000 |
| M384813030US0 | K972463 | 000 |
| M3848130310 | K972463 | 000 |
| M384813031CP1 | K972463 | 000 |
| M384813031US0 | K972463 | 000 |
| M3848130320 | K972463 | 000 |
| M3848130330 | K972463 | 000 |
| M3848130360 | K972463 | 000 |
| M384813036CP1 | K972463 | 000 |
| M384813036US0 | K972463 | 000 |
| M384813029CP1 | K972463 | 000 |
| M3848130290 | K972463 | 000 |
| M384813020US0 | K972463 | 000 |
| M384SCR810010 | K972463 | 000 |
| M384SCR812010 | K972463 | 000 |
| M384SCR812051 | K972463 | 000 |
| M3848120371 | K972463 | 000 |
| M384812037US1 | K972463 | 000 |
| M3848120480 | K972463 | 000 |
| M3848120490 | K972463 | 000 |
| M384812049US0 | K972463 | 000 |
| M3848120550 | K972463 | 000 |
| M3848120560 | K972463 | 000 |
| M3848130200 | K972463 | 000 |
| M384813020CP1 | K972463 | 000 |
| M3848133061 | K972463 | 000 |