The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modification To Bioplate Rigid Bone Plating System For Craniomaxillofacial Surgery.
| Device ID | K023665 |
| 510k Number | K023665 |
| Device Name: | MODIFICATION TO BIOPLATE RIGID 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 | 2002-10-31 |
| Decision Date | 2002-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848110410 | K023665 | 000 |
| M3848130240 | K023665 | 000 |
| M384813024US0 | K023665 | 000 |
| M3848130250 | K023665 | 000 |
| M384813025CP0 | K023665 | 000 |
| M384813025US0 | K023665 | 000 |
| M3848130260 | K023665 | 000 |
| M384813026CP0 | K023665 | 000 |
| M384813026US0 | K023665 | 000 |
| M3848131400 | K023665 | 000 |
| M384813140CP0 | K023665 | 000 |
| M384813140US0 | K023665 | 000 |
| M384813023US0 | K023665 | 000 |
| M384813023CP0 | K023665 | 000 |
| M3848130230 | K023665 | 000 |
| M384P2MC33480 | K023665 | 000 |
| M3848110400 | K023665 | 000 |
| M3848110420 | K023665 | 000 |
| M3848110430 | K023665 | 000 |
| M3848110440 | K023665 | 000 |
| M3848130210 | K023665 | 000 |
| M384813021CP0 | K023665 | 000 |
| M384813021US0 | K023665 | 000 |
| M3848130220 | K023665 | 000 |
| M384813022CP0 | K023665 | 000 |
| M384813022US0 | K023665 | 000 |
| M3848131410 | K023665 | 000 |
| M384813141CP0 | K023665 | 000 |
| M384813141US0 | K023665 | 000 |
| M384815785US0 | K023665 | 000 |
| M3848157860 | K023665 | 000 |
| M3848157880 | K023665 | 000 |
| M384815788US0 | K023665 | 000 |
| M3848157900 | K023665 | 000 |
| M3848157920 | K023665 | 000 |
| M384815792US0 | K023665 | 000 |
| M384P1MC36430 | K023665 | 000 |
| M384P1MC3643US0 | K023665 | 000 |
| M384P2MC82970 | K023665 | 000 |
| M384P2MC8297US0 | K023665 | 000 |
| M384815785CP0 | K023665 | 000 |
| M3848157850 | K023665 | 000 |
| M3848157840 | K023665 | 000 |
| M3848131420 | K023665 | 000 |
| M384813142CP0 | K023665 | 000 |
| M384813142US0 | K023665 | 000 |
| M3848131590 | K023665 | 000 |
| M3848131840 | K023665 | 000 |
| M384813184CP0 | K023665 | 000 |
| M384813184US0 | K023665 | 000 |
| M3848133790 | K023665 | 000 |
| M384813379CP0 | K023665 | 000 |
| M384813379US0 | K023665 | 000 |
| M3848134370 | K023665 | 000 |
| M384813159CP0 | K023665 | 000 |