The following data is part of a premarket notification filed by Responsive Orthopedics Llc with the FDA for Total Knee Arthroplasty System.
| Device ID | K150496 |
| 510k Number | K150496 |
| Device Name: | Total Knee Arthroplasty System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Responsive Orthopedics LLC 1755 Concordia Street Wayzata, MN 55391 |
| Contact | Doug Kohrs |
| Correspondent | Jude Paganelli Cor Medical Ventures LLC 101 N. Acacia Ave, Suite 106 Solana Beach, CA 92075 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-25 |
| Decision Date | 2015-06-12 |
| Summary: | summary |