Data / Medical devices / Thailand / Zimmer Biomet (Thailand) Co., Ltd.
Zimmer Biomet (Thailand) Co., Ltd.: FDA-registered device maker in Bangkok, Thailand, 2 510(k) clearances
Zimmer Biomet (Thailand) Co., Ltd. is registered with the FDA (registration 3013280419) in Bangkok, Thailand. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 25, 2006. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013280419
- Address
- 3 Rajanakarn Building, 2nd Floor, South Sathorn Road, Yannawa, Sathorn Bangkok - Commercial, Bangkok, Thailand, 10120
- Owner or operator
- Zimmer Biomet APAC DFE (10056128)
- Roles
- Exporter to the US
- First device listed
- March 30, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 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 |
| Screw, Fixation, Bone | HWC | 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 |
|---|---|---|---|---|---|---|
| May 25, 2006 | K060525 | VANGUARD REMOVABLE MOLDED POLY TIBIA | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 24, 2006 | K061098 | EBI OPTILOCK PERIARTICULAR PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
Updated May 25, 2006. 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.