The following data is part of a premarket notification filed by Meril Healthcare Pvt. Ltd. with the FDA for Latitud Hip Replacement System.
| Device ID | K183532 |
| 510k Number | K183532 |
| Device Name: | Latitud Hip Replacement System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3, Meril Park, Muktanand Marg, Chala Vapi, IN 396191 |
| Contact | Gayathri Nair |
| Correspondent | Gayathri Nair Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3, Meril Park, Muktanand Marg, Chala Vapi, IN 396191 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-07-18 |