GXR · Class II · 21 CFR 882.5250

FDA Product Code GXR: Cover, Burr Hole

Leading manufacturers include Synthes (Usa), Neos Surgery S.L and Aesculap, Inc..

29
Total
29
Cleared
162d
Avg days
1985
Since
29 devices
25–29 of 29
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096
Image-Guided Neurologics, Inc.
Neurology · 204d
Cleared Aug 14, 1996
GORE BURR HOLE COVER
K960656
W.L. Gore & Associates, Inc.
Neurology · 181d
Cleared Jan 13, 1992
PHOENIX BURR HOLE BUTTON, BURR 1
K913490
Phoenix Bioengineering, Inc.
Neurology · 160d
Cleared Sep 11, 1985
H-H BURR HOLE CATHETER SUPPORT
K853367
Holter-Hausner Intl.
Neurology · 21d