FDA device listing
G7 Acetabular Cup SN 61488 A-A
FDA device listing 1256559903 · Single Source Medical LLC
Key facts
| Proprietary names | G7 Acetabular Cup SN 61488 A-A |
|---|---|
| Owner/operator | Single Source Medical LLC |
| Owner/operator number | 10043888 |
| Product codes | JDI, KWZ, LPH, LZO, OQG, OQI, PBI |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, OQG - Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, OQI - Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, PBI - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3310, 888.3350, 888.3353, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | SINGLE SOURCE MEDICAL LLC |
| Establishment registrations | 3010386387 |
| FEI numbers | 3010386387 |
| 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