The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Rt-plus Pe Insert Clamp.
| Device ID | K021714 |
| 510k Number | K021714 |
| Device Name: | RT-PLUS PE INSERT CLAMP |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-24 |
| Decision Date | 2002-06-21 |
| Summary: | summary |