FDA device listing
Tornier Perform™ Humeral System,TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 Plus stem,TORNIER PERFORM™ HUMERAL SYSTEM Sz 2…
FDA device listing 1981062186 · STRYKER CORP.
Key facts
| Proprietary names | Tornier Perform™ Humeral System,TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 Plus stem,TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 stem,TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 Plus stem,TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 stem |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K201315 |
| Product codes | HSD, KWS, KWT, PAO, 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, PAO - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, 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 Inc., TORNIER, INC., Tornier S.A.S. |
| Establishment registrations | 1649390, 3000931034, 3004983210, 3008337808 |
| FEI numbers | 3000718467, 3000931034, 3004983210, 3008337808 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Specification Developer |
| 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