The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U2 Hip System, Expanded Indications For Use.
| Device ID | K130149 |
| 510k Number | K130149 |
| Device Name: | U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Fang-yuan Ho |
| Correspondent | Fang-yuan Ho UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-22 |
| Decision Date | 2013-06-06 |
| Summary: | summary |