K010840 is an FDA 510(k) clearance for the SYNPLUG. This device is classified as a Cement Obturator (Class II — Special Controls, product code LZN).
Submitted by Isotis NV (North Attleboro, US). The FDA issued a Cleared decision on April 20, 2001, 30 days after receiving the submission on March 21, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K010840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2001 |
| Decision Date | April 20, 2001 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZN — Cement Obturator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |