510(k) K971682

J-FX CERCLAGE SYSTEM by Johnson & Johnson Professionals, Inc. — Product Code LRN

K971682 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "J-FX CERCLAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 1997. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.