The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for United U2 Xpe Total Knee System.
| Device ID | K103733 |
| 510k Number | K103733 |
| Device Name: | UNITED U2 XPE TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2011-08-02 |
| Summary: | summary |