Data / Medical devices / Indonesia / PT. Team Metal Indonesia
PT. Team Metal Indonesia: FDA-registered device maker in BATAM Riau, Indonesia, 3 510(k) clearances
PT. Team Metal Indonesia is registered with the FDA (registration 3007516837) in BATAM Riau, Indonesia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 22, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007516837
- Address
- JLN. Brigjen Katamso No. 6 - 8 Bintang Industrial Park Ii, Tanjung Uncang, BATAM Riau, Indonesia, 29430
- Owner or operator
- TEAM-METAL(S) PRIVATE LIMITED (10028595)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 15, 2009
- Registered through
- 2026
- Brand names listed
- DYONICS LAPAROSCOPY SYSTEM, PSN A/S PROV SHIM 10MM CD, PSN A/S PROV SHIM 10MM EF, PSN A/S PROV SHIM 10MM GH, PSN A/S PROV SHIM 12MM CD, PSN A/S PROV SHIM 12MM EF, PSN A/S PROV SHIM 12MM GH, PSN A/S PROV SHIM 14MM CD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 22, 2013 | K130143 | PERSONA NATURAL TIBIA BASEPLATES | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 9, 2012 | K122765 | PERSONA NATURAL TIBIA BASEPLATES | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 9, 1992 | K914919 | SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM | GCJ | Substantially Equivalent | Smith & Nephew Dyonics, 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/Metal/Polymer
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Updated February 22, 2013. 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.