510(k) K950009

POWERGRIP(TM) COMPRESSION FIXATION DEVICE by Synvasive Technology, Inc. — Product Code JDW

K950009 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "POWERGRIP(TM) COMPRESSION FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.