GXO · Class II · 21 CFR 882.5900

FDA Product Code GXO: Strip, Craniosynostosis, Preformed

Leading manufacturers include Codman & Shurtleff, Inc. and W.L. Gore & Associates, Inc..

2
Total
2
Cleared
104d
Avg days
1996
Since

FDA 510(k) Cleared Strip, Craniosynostosis, Preformed Devices (Product Code GXO)

2 devices
1–2 of 2
Cleared Feb 25, 2004
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
K033395
Codman & Shurtleff, Inc.
Neurology · 125d
Cleared Jul 31, 1996
PRECLUDE SYNBLOC MEMBRANE
K961802
W.L. Gore & Associates, Inc.
Neurology · 83d

About Product Code GXO - Regulatory Context