510(k) K831042

CHEMONUCLEOLYSIS TABLE EXTENSION by Orthopedic Systems, Inc. — Product Code FSE

K831042 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "CHEMONUCLEOLYSIS TABLE EXTENSION". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.