The following data is part of a premarket notification filed by Iconacy Orthopedic Implants, Llc with the FDA for Iconacy I-hip System.
| Device ID | K131279 |
| 510k Number | K131279 |
| Device Name: | ICONACY I-HIP 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M914011010306400 | K131279 | 000 |
| M914011010205200 | K131279 | 000 |
| M914011010205000 | K131279 | 000 |
| M914011010204800 | K131279 | 000 |
| M914011010204600 | K131279 | 000 |
| M914011010106400 | K131279 | 000 |
| M914011010106200 | K131279 | 000 |
| M914011010106000 | K131279 | 000 |
| M914011010105800 | K131279 | 000 |
| M914011010105600 | K131279 | 000 |
| M914011010105400 | K131279 | 000 |
| M914011010105200 | K131279 | 000 |
| M914011010105000 | K131279 | 000 |
| M914011010104800 | K131279 | 000 |
| M914011010205400 | K131279 | 000 |
| M914011010205600 | K131279 | 000 |
| M914011010306200 | K131279 | 000 |
| M914011010306000 | K131279 | 000 |
| M914011010305800 | K131279 | 000 |
| M914011010305600 | K131279 | 000 |
| M914011010305400 | K131279 | 000 |
| M914011010305200 | K131279 | 000 |
| M914011010305000 | K131279 | 000 |
| M914011010304800 | K131279 | 000 |
| M914011010304600 | K131279 | 000 |
| M914011010206400 | K131279 | 000 |
| M914011010206200 | K131279 | 000 |
| M914011010206000 | K131279 | 000 |
| M914011010205800 | K131279 | 000 |
| M914011010104600 | K131279 | 000 |