JXH — Methyl Methacrylate For Aneurysmorrhaphy Class II

FDA Device Classification

FDA product code JXH covers "Methyl Methacrylate For Aneurysmorrhaphy", a Class II medical device regulated under 21 CFR 882.5030. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JXH
Device Class
Class II
Regulation Number
882.5030
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K071776codman and shurtleffANEUROPLASTIC, MODEL 43-1290July 26, 2007
K882072karlin technologyORTHOPAEDIC AND SPINAL RING CURRETTESJune 17, 1988
K873688dentsply intlANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIALOctober 26, 1987