FDA PRODUCT CODE · CLASS II
QZZ — Limb And Joint Salvage Device With Coating For Bacteria Reduction
A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products.
Recent clearances
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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