K032685 is an FDA 510(k) clearance for the CEMSTOP CEMENT RESTRICTOR. This device is classified as a Cement Obturator (Class II - Special Controls, product code LZN).
Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on November 26, 2003, 89 days after receiving the submission on August 29, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K032685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2003 |
| Decision Date | November 26, 2003 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZN — Cement Obturator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |