K041754 is an FDA 510(k) clearance for the STRYKER MAESTRO SYSTEM. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 7, 2004, 70 days after receiving the submission on June 29, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K041754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2004 |
| Decision Date | September 07, 2004 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |