The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Tc-plus Porous Tibial Components.
| Device ID | K011288 |
| 510k Number | K011288 |
| Device Name: | TC-PLUS POROUS TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-27 |
| Decision Date | 2001-05-24 |