The following data is part of a premarket notification filed by Iconacy Orthopedic Implants, Llc with the FDA for Ioi Total Hip.
| Device ID | K121034 |
| 510k Number | K121034 |
| Device Name: | IOI TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ICONACY ORTHOPEDIC IMPLANTS, LLC PO BOX 1033 Warsaw, IN 46581 -1033 |
| Contact | Roy Y Hori, Phd |
| Correspondent | Roy Y Hori, Phd ICONACY ORTHOPEDIC IMPLANTS, LLC PO BOX 1033 Warsaw, IN 46581 -1033 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M914011020301201 | K121034 | 000 |
| M914011020100001 | K121034 | 000 |
| M914011010406400 | K121034 | 000 |
| M914011010406200 | K121034 | 000 |
| M914011010406000 | K121034 | 000 |
| M914011010405800 | K121034 | 000 |
| M914011010405600 | K121034 | 000 |
| M914011010405400 | K121034 | 000 |
| M914011010405200 | K121034 | 000 |
| M914011010405000 | K121034 | 000 |
| M914011010404800 | K121034 | 000 |
| M914011020100201 | K121034 | 000 |
| M914011020100401 | K121034 | 000 |
| M914011020100801 | K121034 | 000 |
| M914011020300801 | K121034 | 000 |
| M914011020300401 | K121034 | 000 |
| M914011020300201 | K121034 | 000 |
| M914011020300001 | K121034 | 000 |
| M914011020201201 | K121034 | 000 |
| M914011020200801 | K121034 | 000 |
| M914011020200401 | K121034 | 000 |
| M914011020200201 | K121034 | 000 |
| M914011020200001 | K121034 | 000 |
| M914011020101201 | K121034 | 000 |
| M914011010404600 | K121034 | 000 |