K853066 is an FDA 510(k) clearance for the MAYFIELD DISPOSABLE SKULL PINS. This device is classified as a Tong, Skull For Traction (Class II - Special Controls, product code HAX).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on August 8, 1985, 20 days after receiving the submission on July 19, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5960.
| 510(k) Number | K853066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1985 |
| Decision Date | August 08, 1985 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HAX - Tong, Skull For Traction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5960 |