The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Osseous Fixation System(s).
| Device ID | K960914 |
| 510k Number | K960914 |
| Device Name: | 3I OSSEOUS FIXATION SYSTEM(S) |
| Classification | Plate, Bone |
| Applicant | IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Contact | William F Conety |
| Correspondent | William F 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 | 1996-03-06 |
| Decision Date | 1996-04-04 |
| Summary: | summary |