FDA Registration
Inactive
🇲🇾 Malaysia
ZIMMER MEDICAL (Malaysia) SDN BHD
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- ZIMMER MEDICAL (Malaysia) SDN BHD
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Menara Symphony, 01-18, 18th Floor, No 5 Jalan Prof. Khoo Kay Kim, Seksyen 13
- City
- PETALING JAYA Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K191625
Owner / Operator
- Firm Name
- Zimmer Biomet APAC DFE
- Operator Number
- 10056128
- Address
- Unit 01-10,19/F, Metro Plaza 555 Lou Shan Guan Road, Changning District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200051
- Country
- CN
US Agent
- Business Name
- ZIMMER BIOMET
- Contact Name
- STEPHANIE LYNCH
- Address
- 1800 W Center St
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 715 9289253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2026-05-07 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2026-05-07 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-05-07 |
Proprietary Names
Persona Revision Knee System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device