Meril Healthcare Pvt. Ltd.
Vapi, IN
MERIL HEALTHCARE PVT. LTD. appears in FDA device records in Vapi, IN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Meril Healthcare Pvt. Ltd. between 2017 and 2023. The busiest year on record is 2018, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222436 | Latitud™ Hip Replacement System | LPH | Substantially Equivalent | |
| K222816 | Opulent TiNbN Coated Knee | JWH | Substantially Equivalent | |
| K212839 | Opulent TiNbN Coated Knee | JWH | Substantially Equivalent | |
| K183532 | Latitud Hip Replacement System | LZO | Substantially Equivalent | |
| K172857 | Latitud Hip Replacement System | LPH | Substantially Equivalent | |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | HRS | Substantially Equivalent | |
| K172936 | Destiknee™ Total Knee System | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010846112 | 3010846112 | MERIL HEALTHCARE PVT. LTD. | Meril Campus, B. No. 8-F1, B. No. 10 B. No. 5-F0, B. No. 6-F2, Vapi Gujarat 396191 IN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRSPlate, Fixation, Bone
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain