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 | K160266 |
| 510k Number | K160266 |
| Device Name: | ICONACY(TM) I-Hip(TM) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ICONACY ORTHOPEDIC IMPLANTS, LLC 4130 CORRIDOR DRIVE Warsaw, IN 46582 |
| Contact | Thomas R. Allen |
| Correspondent | Carol Vierling C L VIERLING, LLC 3560 GREYSTONE DRIVE Warsaw, IN 46582 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-04-08 |
| Summary: | summary |