The following data is part of a premarket notification filed by Iconacy Orthopedic Implants, Llc with the FDA for Iconacy I-hip System, Gradual Transitioning (gt) Femoral System.
| Device ID | K133228 |
| 510k Number | K133228 |
| Device Name: | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ICONACY ORTHOPEDIC IMPLANTS, LLC 4130 CORRIDOR DRIVE Warsaw, IN 46582 |
| Contact | Marc E Ruhling |
| Correspondent | Marc E Ruhling ICONACY ORTHOPEDIC IMPLANTS, LLC 4130 CORRIDOR DRIVE Warsaw, IN 46582 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-01-17 |
| Summary: | summary |