K060750 is an FDA 510(k) clearance for the STRYKER INJECTABLE CEMENT. This device is classified as a Cement, Ear, Nose And Throat (Class II - Special Controls, product code NEA).
Submitted by Stryker Cmf (Kalamazoo, US). The FDA issued a Cleared decision on April 19, 2006, 29 days after receiving the submission on March 21, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K060750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2006 |
| Decision Date | April 19, 2006 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NEA — Cement, Ear, Nose And Throat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |