K053045 is an FDA 510(k) clearance for the MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020. This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on November 21, 2005, 24 days after receiving the submission on October 28, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K053045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2005 |
| Decision Date | November 21, 2005 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBL — Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |