510(k) K001507

MICROPERFORATION INSTRUMENT by Smith & Nephew, Inc. — Product Code LXH

K001507 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MICROPERFORATION INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 14, 2000. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.