Strip, Craniosynostosis, Preformed
The Preformed Craniosynostosis Strip is an implanted neurosurgical device used in the surgical correction of craniosynostosis, a condition where skull sutures fuse prematurely in infants, by providing a structural element to guide or maintain proper skull growth. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and carries an implant designation. The product code is GXO under regulation 21 CFR 882.5900 in the Neurology specialty. The implant flag is active for this device.
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Basic Information
- Product Code
- GXO
- Device Class
- FDA class 2
- Regulation Number
- 882.5900
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K033395 | 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 | Feb 25, 2004 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K961802 | PRECLUDE SYNBLOC MEMBRANE | Jul 31, 1996 | Substantially Equivalent | W. L. Gore & Associates, Inc. |