The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Uc-plus Solution Unicondylar Knee System.
| Device ID | K982859 |
| 510k Number | K982859 |
| Device Name: | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1999-07-30 |
| Summary: | summary |