510(k) K904243

TSRH VARIABLE ANGLE SACRAL SCREW by Danek Medical, Inc. — Product Code KWP

K904243 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "TSRH VARIABLE ANGLE SACRAL SCREW". The FDA issued a decision of SN on January 22, 1992. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.