FDA device listing
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…
FDA device listing 1522406868 · TEAM-METAL(S) PRIVATE LIMITED
Key facts
| Proprietary names | 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,PSN A/S PROV SHIM 14MM EF,PSN A/S PROV SHIM 14MM GH,PSN PROV MLC LCK DWN SCR LONG,PSN PROV MLC LCK DWN SCR SHORT |
|---|---|
| Owner/operator | TEAM-METAL(S) PRIVATE LIMITED |
| Owner/operator number | 10028595 |
| Product codes | MBH |
| Device names | MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3565 |
| Review panels | Orthopedic |
| Registered establishments | PT. TEAM METAL INDONESIA |
| Establishment registrations | 3007516837 |
| FEI numbers | 3007516837 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database