The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Rt-plus Modular Cemented Knee Components.
| Device ID | K003504 |
| 510k Number | K003504 |
| Device Name: | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. #15-100 San Diego, CA 92121 -1194 |
| Contact | Harmtmut Loch |
| Correspondent | Harmtmut Loch PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. #15-100 San Diego, CA 92121 -1194 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-05-11 |