K861822 is an FDA 510(k) clearance for the MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on July 11, 1986, 60 days after receiving the submission on May 12, 1986.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K861822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1986 |
| Decision Date | July 11, 1986 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |