FDA device listing
Z1 Hip System
FDA device listing 1427589678 · Paragon Medical
Key facts
| Proprietary names | Z1 Hip System |
|---|---|
| Owner/operator | Paragon Medical |
| Owner/operator number | 9011072 |
| Product codes | KWY, KWZ, LWJ, LZO, MEH |
| Device names | KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3310, 888.3353, 888.3360, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | Paragon Medical Inc., PARAGON MEDICAL, INC. |
| Establishment registrations | 1834331, 1835831 |
| FEI numbers | 1000306340, 3001814066 |
| 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