FDA device listing
Custom Made Distal Humeral Replacement incl. Humeral Cone,custom made elbow replacements
FDA device listing 1767055325 · WALDEMAR LINK GMBH & CO. KG
Key facts
| Proprietary names | Custom Made Distal Humeral Replacement incl. Humeral Cone,custom made elbow replacements |
|---|---|
| Owner/operator | WALDEMAR LINK GMBH & CO. KG |
| Owner/operator number | 8010091 |
| Product codes | JDC |
| Device names | JDC - Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3150 |
| Review panels | Orthopedic |
| Registered establishments | Waldemar Link GmbH & Co. KG |
| Establishment registrations | 3004371426 |
| FEI numbers | 3003386935 |
| Establishment operations | 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