The following data is part of a premarket notification filed by Meril Healthcare Pvt. Ltd. with the FDA for Opulent Tinbn Coated Knee.
| Device ID | K222816 |
| 510k Number | K222816 |
| Device Name: | Opulent TiNbN Coated Knee |
| 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 | Neelam Desai |
| Correspondent | Neelam Desai Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3 , Meril Park Muktanand Marg, Chala Vapi, IN 396191 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-19 |
| Decision Date | 2022-11-18 |