K180541 is an FDA 510(k) clearance for the DePuy Synthes 2.0 mm Quick Insertion Screws. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on November 21, 2018, 265 days after receiving the submission on March 1, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K180541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2018 |
| Decision Date | November 21, 2018 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |