K024022 is an FDA 510(k) clearance for the OSTEO-CABLE SLEEVE. This device is classified as a Applier, Cerclage (Class I - General Controls, product code HXN).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 23, 2003, 49 days after receiving the submission on December 5, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K024022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2002 |
| Decision Date | January 23, 2003 |
| Days to Decision | 49 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HXN — Applier, Cerclage |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |