The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U1 Hip System - Bipolar.
| Device ID | K050269 |
| 510k Number | K050269 |
| Device Name: | U1 HIP SYSTEM - BIPOLAR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Gene Huang |
| Correspondent | Gene Huang UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-04 |
| Decision Date | 2005-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712602344432 | K050269 | 000 |
| 04711605564908 | K050269 | 000 |
| 04711605564892 | K050269 | 000 |
| 04711605564885 | K050269 | 000 |
| 04711605564878 | K050269 | 000 |
| 04711605564861 | K050269 | 000 |
| 04711605564854 | K050269 | 000 |
| 04711605564847 | K050269 | 000 |
| 04711605564830 | K050269 | 000 |
| 04711605564915 | K050269 | 000 |
| 04711605564922 | K050269 | 000 |
| 04712602344425 | K050269 | 000 |
| 04712602344418 | K050269 | 000 |
| 04712602344401 | K050269 | 000 |
| 04712602343978 | K050269 | 000 |
| 04712602343961 | K050269 | 000 |
| 04712602343954 | K050269 | 000 |
| 04712602343947 | K050269 | 000 |
| 04711605564939 | K050269 | 000 |
| 04711605564823 | K050269 | 000 |