K153587 is an FDA 510(k) clearance for the Taps for Resorbable Screws. This device is classified as a Drills, Burrs, Trephines & Accessories (manual) (Class II - Special Controls, product code HBG).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on January 18, 2017, 399 days after receiving the submission on December 16, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4300.
| 510(k) Number | K153587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2015 |
| Decision Date | January 18, 2017 |
| Days to Decision | 399 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 |