K042591 is an FDA 510(k) clearance for the SMARTMIX PRE-FILLED MIXING SYSTEM. This device is classified as a Dispenser, Cement (Class I - General Controls, product code KIH).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 22, 2004, 29 days after receiving the submission on September 23, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4200.
| 510(k) Number | K042591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2004 |
| Decision Date | October 22, 2004 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KIH - Dispenser, Cement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4200 |