The following data is part of a premarket notification filed by Iconacy Orthopedic Implants, Llc with the FDA for Iconacy(tm) I-hip (tm).
| Device ID | K151307 |
| 510k Number | K151307 |
| Device Name: | ICONACY(TM) I-Hip (TM) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ICONACY ORTHOPEDIC IMPLANTS, LLC 4130 CORRIDOR DRIVE Warsaw, IN 46582 |
| Contact | Roy Y Hori |
| Correspondent | Roy Y Hori ICONACY ORTHOPEDIC IMPLANTS, LLC 4130 CORRIDOR DRIVE Warsaw, IN 46582 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-02-26 |
| Summary: | summary |