K072271 is an FDA 510(k) clearance for the STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on December 18, 2007, 125 days after receiving the submission on August 15, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K072271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2007 |
| Decision Date | December 18, 2007 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |