K023680 is an FDA 510(k) clearance for the BIOBUCK CEMENT RESTRICTOR. This device is classified as a Cement Obturator (Class II - Special Controls, product code LZN).
Submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on November 19, 2002, 18 days after receiving the submission on November 1, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K023680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2002 |
| Decision Date | November 19, 2002 |
| Days to Decision | 18 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 |