FDA device listing
CLS Brevius Stem with Kinectiv Technology
FDA device listing 1473834751 · ZIMMER GMBH
Key facts
| Proprietary names | CLS Brevius Stem with Kinectiv Technology |
|---|---|
| Owner/operator | ZIMMER GMBH |
| Owner/operator number | 9064978 |
| Premarket submissions | K110836 |
| Product codes | JDI, JDL, KWA, KWZ, LPH, LWJ, LZO |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, JDL - Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), KWA - Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II, Class III |
| Classification regulations (21 CFR) | 888.3310, 888.3320, 888.3330, 888.3350, 888.3353, 888.3358, 888.3360 |
| Review panels | Orthopedic |
| Registered establishments | ZIMMER GMBH |
| Establishment registrations | 9613350 |
| FEI numbers | 3005233524 |
| Establishment operations | Manufacturer |
| 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