K201561 is an FDA 510(k) clearance for the Membrane Screws and Membrane Tacks. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Neoss Limited (Harrogate, GB). The FDA issued a Cleared decision on October 5, 2020, 117 days after receiving the submission on June 10, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K201561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2020 |
| Decision Date | October 05, 2020 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL - Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |