510(k) K915800

BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN by Bremer Medical, Inc. — Product Code JEC

K915800 is an FDA 510(k) premarket notification submitted by Bremer Medical, Inc. for the device "BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN". The FDA issued a decision of Substantially Equivalent on March 16, 1992. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Bremer Medical, Inc. has at least 1 other 510(k) clearance on record.