Data / Medical devices / India / Meril Healthcare Pvt. Ltd.
Meril Healthcare Pvt. Ltd.: FDA-registered device maker in Vapi Gujarat, India, 5 510(k) clearances
Meril Healthcare Pvt. Ltd. is registered with the FDA (registration 3010846112) in Vapi Gujarat, India. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010846112
- Address
- Meril Campus, B. No. 8-F1, B. No. 10 B. No. 5-F0, B. No. 6-F2 Muktanand Marg, Vapi Gujarat, India, 396191
- Owner or operator
- Meril Healthcare Pvt. Ltd. (10049149)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 21, 2015
- Registered through
- 2026
- Brand names listed
- ARMAR, ARTIS, Destiknee, FIXION, FREEDOM(R) STEMMED TIBIAL COMPONENTS, Freedom (R) PCK Components, Freedom® CR Femoral Component, Freedom® Metal Backed Tibial Component and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 16, 2021 | K212839 | Opulent TiNbN Coated Knee | JWH | Substantially Equivalent | Meril Healthcare Pvt. , Ltd. | accessdata.fda.gov |
| July 18, 2019 | K183532 | Latitud Hip Replacement System | LZO | Substantially Equivalent | Meril Healthcare Pvt. , Ltd. | accessdata.fda.gov |
| July 19, 2018 | K172857 | Latitud Hip Replacement System | LPH | Substantially Equivalent | Meril Healthcare Pvt. , Ltd. | accessdata.fda.gov |
| March 8, 2018 | 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 | Meril Healthcare Pvt. , Ltd. | accessdata.fda.gov |
| December 19, 2016 | K160771 | Destiknee Total Knee System | JWH | Substantially Equivalent | Meril Healthcare Private Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Updated November 16, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.