FDA device listing
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA device listing 1911063501 · Harwood Design, Inc.
Key facts
| Owner/operator | Harwood Design, Inc. |
|---|---|
| Owner/operator number | 10043110 |
| Product codes | LPH, LZO, MBL, OQG |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, MBL - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, OQG - Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | HARWOOD DESIGN, INC. |
| Establishment registrations | 3003761012 |
| FEI numbers | 3003761012 |
| 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