The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for United U2 Patella.
| Device ID | K082469 |
| 510k Number | K082469 |
| Device Name: | UNITED U2 PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Rudy Chen |
| Correspondent | Rudy Chen UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-27 |
| Decision Date | 2008-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712602348942 | K082469 | 000 |
| 04712602348935 | K082469 | 000 |