FDA 510(k) Applications for Medical Device Product Code "HAX"
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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 |