Yes, and this may be a partial explanation as to why so many Exactech devices have failed. 501k clearance basically shortens the FDA approval process. Companies who register their products for 501k clearance do so because they believe that their products are safe and effective. Therefore, the companies believe their products don’t need to go through the whole FDA approval process to determine safety and effectiveness. Had Exactech medical devices gone through the whole FDA approval process, maybe they would’ve discovered the packaging failures that led to oxidation and breakdown.