510(k) K100120

ALEXIS ORTHOPAEDIC WOUND RETRACTOR by Applied Medical Resources Corp. — Product Code KGW

K100120 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "ALEXIS ORTHOPAEDIC WOUND RETRACTOR". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.