FDA device listing
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA device listing 1720999318 · DePuy Synthes, Inc.
Key facts
| Owner/operator | DePuy Synthes, Inc. |
|---|---|
| Owner/operator number | 1818910 |
| Premarket submissions | K243248 |
| Product codes | KWS, KWT, MBF, PAO, PKC |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, MBF - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, PAO - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented, PKC - Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3650, 888.3660, 888.3670 |
| Review panels | Orthopedic |
| Registered establishments | Depuy Ireland UC, DEPUY ORTHOPAEDICS, INC. |
| Establishment registrations | 1818910, 3015516266 |
| FEI numbers | 1818910, 3015516266 |
| Establishment operations | 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