PRECLUDE SYNBLOC MEMBRANE
Device Facts
| Record ID | K961802 |
|---|---|
| Device Name | PRECLUDE SYNBLOC MEMBRANE |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | GXO · Neurology |
| Decision Date | Jul 31, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
