The following data is part of a premarket notification filed by Meril Healthcare Private Limited with the FDA for Destiknee Total Knee System.
| Device ID | K160771 |
| 510k Number | K160771 |
| Device Name: | Destiknee Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MERIL HEALTHCARE PRIVATE LIMITED SURVEY NO. 135/2/B & 174/2, H1-H3 , MERIL PARK, MUKTANAND MARG , CHALA. Vapi, IN 396191 |
| Contact | Umesh Sharma |
| Correspondent | Jon Ward AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-12-19 |
| Summary: | summary |