FDA device listing
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA device listing 1310990545 · ARTHREX, INC.
Key facts
| Owner/operator | ARTHREX, INC. |
|---|---|
| Owner/operator number | 1220287 |
| Premarket submissions | K222007 |
| Product codes | KWS, LLZ, PHX, QHE |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, LLZ - System, Image Processing, Radiological, PHX - Shoulder Prosthesis, Reverse Configuration, QHE - Shoulder Arthroplasty Implantation System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660, 892.2050 |
| Review panels | Orthopedic, Radiology |
| Registered establishments | Arthrex, Inc., ARTHREX, INC., Arthrex Japan G.K. (Shinjuku), Arthrex Manufacturing Inc., Arthrex New Zealand Limited, Arthrex (Shanghai) Co., Ltd., Arthrex Singapore Pte Ltd. |
| Establishment registrations | 1220246, 3010331645, 3012470322, 3014004349, 3014262693, 3015231789, 3020704423 |
| FEI numbers | 1220246, 3010331645, 3012470322, 3014004349, 3014262693, 3015231789, 3020704423 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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