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510(k) Data Aggregation
(84 days)
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.
StelKast 32mm Modular Ceramic Femoral Head
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter granting 510(k) clearance for the "StelKast 32mm Modular Ceramic Femoral Head" and its Indications For Use. It confirms the device's substantial equivalence to a legally marketed predicate device but does not detail any specific performance acceptance criteria or the results of a study to demonstrate compliance with such criteria.
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