K022370 is an FDA 510(k) clearance for the FRAMELOCK. This device is classified as a Drills, Burrs, Trephines & Accessories (manual) (Class II - Special Controls, product code HBG).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 18, 2002, 88 days after receiving the submission on July 22, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4300.
| 510(k) Number | K022370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2002 |
| Decision Date | October 18, 2002 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBG — Drills, Burrs, Trephines & Accessories (manual) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4300 |