FDA device listing
Aequalis Ascend Flex Shoulder System,Aequalis Reversed Shoulder Prosthesis
FDA device listing 1696456786 · STRYKER CORP.
Key facts
| Proprietary names | Aequalis Ascend Flex Shoulder System,Aequalis Reversed Shoulder Prosthesis |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K151293 |
| Product codes | HSD, KWS, KWT, PHX |
| Device names | HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, PHX - Shoulder Prosthesis, Reverse Configuration |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3650, 888.3660, 888.3690 |
| Review panels | Orthopedic |
| Registered establishments | Stryker Macroom, Tornier S.A.S., TORNIER S.A.S |
| Establishment registrations | 3000931034, 3008337808, 3008388276 |
| FEI numbers | 3000931034, 3008337808, 3008388276 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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