FDA Registration
Active
🇮🇩 Indonesia
ZIMMER PERSONA PERSONALIZED KNEE SYSTEM
Reg #: 3007516837
·
FEI: 3007516837
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- PT. TEAM-METAL INDONESIA
- Registration Number
- 3007516837
- FEI Number
- 3007516837
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- JL BRIGJEN KATAMSO NO7-8,KAWASAN BINTANG INDUSTRI II, TANJUNG UNCANG. P. BATAM
- City
- BATAM Kepulauan Riau
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K130143
Owner / Operator
- Firm Name
- TEAM-METAL(S) PRIVATE LIMITED
- Operator Number
- 10028595
- Address
- 31KAKI BUKIT VIEW
- City
- SINGAPORE
- State
- SG-NOTA
- Postal Code
- 415964
- Country
- SG
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-07-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2013-07-04 |
Proprietary Names
ZIMMER PERSONA PERSONALIZED KNEE SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device