The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Vks/tc-plus Revision Knee.
| Device ID | K032215 |
| 510k Number | K032215 |
| Device Name: | VKS/TC-PLUS REVISION KNEE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-08-08 |
| Summary: | summary |