The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U2 Total Knee System - Psa Type, Offset Stem Adapter.
| Device ID | K131116 |
| 510k Number | K131116 |
| Device Name: | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER |
| 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 | 2013-04-22 |
| Decision Date | 2013-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712771509915 | K131116 | 000 |
| 04712771509908 | K131116 | 000 |
| 04712771509892 | K131116 | 000 |