FDA device listing
Zimmer BF Humeral Head 15mm x 40mm (430054015),Zimmer BF Humeral Head 18mm x 40mm (430054018),Zimmer BF Humeral Head…
FDA device listing 1021618283 · Lincotek Medical, LLC
Key facts
| Proprietary names | Zimmer BF Humeral Head 15mm x 40mm (430054015),Zimmer BF Humeral Head 18mm x 40mm (430054018),Zimmer BF Humeral Head 18mm x 46mm (430054618),Zimmer BF Humeral Head 21mm x 46mm (430054621),Zimmer BF Humeral Head 21mm x 52mm (430055221),Zimmer BF Humeral Head 24mm x 46mm (430054624),Zimmer BF Humeral Head 24mm x 52mm (430055224),Zimmer BF Humeral Head 27mm x 52mm (430055227),Zimmer BF Humeral Head… |
|---|---|
| Owner/operator | Lincotek Medical, LLC |
| Owner/operator number | 9057128 |
| Product codes | HSD, KWT |
| Device names | HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3650, 888.3690 |
| Review panels | Orthopedic |
| Registered establishments | Lincotek Medical LLC |
| Establishment registrations | 3010039400 |
| FEI numbers | 3010039400 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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