The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Oral/maxillofacial Bone Fixation System: Cocrmo Alloy (vitalium) Bone-mesh/plate & Screws.
| Device ID | K952812 |
| 510k Number | K952812 |
| Device Name: | 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS |
| Classification | Plate, Bone |
| Applicant | IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Contact | William G Conety |
| Correspondent | William G Conety IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-08-30 |