GXO — Strip, Craniosynostosis, Preformed Class II
FDA product code GXO covers "Strip, Craniosynostosis, Preformed", a Class II medical device regulated under 21 CFR 882.5900. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXO
- Device Class
- Class II
- Regulation Number
- 882.5900
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes