FDA device listing
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FDA device listing 1098786236 · ARCH Medical Solutions - Seabrook
Key facts
| Owner/operator | ARCH Medical Solutions - Seabrook |
|---|---|
| Owner/operator number | 1221763 |
| Product codes | JDI, JDL, KWA, KWL, KWY, KWZ, LPH, LZO, MEH, OQG |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, JDL - Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), KWA - Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), KWL - Prosthesis, Hip, Hemi-, Femoral, Metal, KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 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, MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, OQG - Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 888.3310, 888.3320, 888.3330, 888.3350, 888.3353, 888.3358, 888.3360, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | ARCH Medical Solutions - Seabrook |
| Establishment registrations | 1221763 |
| FEI numbers | 1221763 |
| 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