Product code GXO— Neurology
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
- Classification name
- Strip, Craniosynostosis, Preformed
- Device class
- Class 2
- Regulation
- 21 CFR 882.5900
- Advisory panel
- Neurology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GXO
FDA has cleared devices under product code GXO between 1996 and 2004, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2004
- 1996
Top applicants under product code GXO
Recent clearances under product code GXO
Data sourced from openFDA. This site is unofficial and independent of the FDA.