510(k) K943855

BONE FIXATION NAIL by Acu Med, Inc. — Product Code JDS

K943855 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "BONE FIXATION NAIL". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Acu Med, Inc. has at least 10 other 510(k) clearances on record.