The following data is part of a premarket notification filed by Meril Healthcare Pvt. Ltd. with the FDA for Destiknee™ Total Knee System.
| Device ID | K172936 |
| 510k Number | K172936 |
| Device Name: | Destiknee™ Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3, Meril Park, Muktanand Marg, Chala Vapi, IN 396191 |
| Contact | Bhavik Gondaliya |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2017-11-30 |
| Summary: | summary |