Data / Medical devices / India / Zimmer India Private Limited
Zimmer India Private Limited: FDA-registered device maker in Gurugram Haryana, India, 1 510(k) clearance
Zimmer India Private Limited is registered with the FDA (registration 3048147961) in Gurugram Haryana, India. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 5, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3048147961
- Address
- Unit 704/705/706, 7th Floor, Vatika City Point Mehrauli-Gurgaon Road, DLF Phase 2, Sector 25, Gurugram Haryana, India, 122002
- Owner or operator
- Zimmer Biomet APAC DFE (10056128)
- Roles
- Exporter to the US
- First device listed
- May 7, 2026
- Registered through
- 2026
- Brand names listed
- Persona Revision Knee System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | 2 | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| September 5, 2019 | K191625 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated September 5, 2019. 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.