510(k) K101609

SELF RETAINING SOFT TISSUE RETRACTOR by Koros USA, Inc. — Product Code LXH

K101609 is an FDA 510(k) premarket notification submitted by Koros USA, Inc. for the device "SELF RETAINING SOFT TISSUE RETRACTOR". The FDA issued a decision of Substantially Equivalent on December 9, 2010. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Koros USA, Inc. has at least 3 other 510(k) clearances on record.