K180064 is an FDA 510(k) clearance for the OsteoFab Patient Specific Cranial Device. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Oxford Performance Materials, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 27, 2018, 199 days after receiving the submission on January 9, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K180064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2018 |
| Decision Date | July 27, 2018 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN - Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |