K190172 is an FDA 510(k) clearance for the Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Stryker (Kalamazoo, US). The FDA issued a Cleared decision on June 14, 2019, 133 days after receiving the submission on February 1, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K190172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2019 |
| Decision Date | June 14, 2019 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE — Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |