FDA 510(k) Applications for Medical Device Product Code "HAX"
(Tong, Skull For Traction)

FDA 510(k) Number Applicant Device Name Decision Date
K980689 FRIDDLE'S ORTHOPEDIC APPLIANCES, INC. FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM 02/18/1999
K051918 JEROME MEDICAL RESOLVE OPEN BACK HALO RINGS 08/17/2005
K071173 OSSUR AMERICANS (FORMERLY THE JEROME GROUP) RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D 05/25/2007
K090733 PMT CORP. PMT HALO SYSTEM 07/28/2009
K003662 SPINE WORKS SPINE WORKS COLLAR 07/09/2001
K023959 THE JEROME GROUP, INC. JEROME GLASS RING 02/21/2003


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact