The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Vks Knee System.
| Device ID | K022204 |
| 510k Number | K022204 |
| Device Name: | VKS KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-10-18 |
| Summary: | summary |