FDA device listing
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
FDA device listing 1112476228 · ARTHREX, INC.
Key facts
| Owner/operator | ARTHREX, INC. |
|---|---|
| Owner/operator number | 1220287 |
| Premarket submissions | K201542 |
| Product codes | PKC, QHQ |
| Device names | PKC - Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, QHQ - Total Shoulder Arthroplasty System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660 |
| Review panels | Orthopedic |
| Registered establishments | Arthrex Australia Pty Ltd., Arthrex Distribution Hub EMEA B.V., Arthrex GmbH, Arthrex, Inc., ARTHREX, INC., Arthrex New Zealand Limited, Arthrex (Shanghai) Co., Ltd., Arthrex Singapore Pte Ltd. |
| Establishment registrations | 1220246, 3002579136, 3010331645, 3014004349, 3014262693, 3016851379, 3019269298, 3020704423 |
| FEI numbers | 1220246, 3002579136, 3010331645, 3014004349, 3014262693, 3016851379, 3019269298, 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
- 10–99 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