K002990 is an FDA 510(k) clearance for the VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001. This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Vascular Technology Incorporated (Lowell, US). The FDA issued a Cleared decision on November 6, 2000, 42 days after receiving the submission on September 25, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K002990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2000 |
| Decision Date | November 06, 2000 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBL — Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |