The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Bioresorbable Fixation Tack.
| Device ID | K972480 |
| 510k Number | K972480 |
| Device Name: | 3I BIORESORBABLE FIXATION TACK |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William G Conety |
| Correspondent | William G Conety IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-12-23 |
| Summary: | summary |