K993583 is an FDA 510(k) clearance for the ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on November 10, 1999, 19 days after receiving the submission on October 22, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K993583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1999 |
| Decision Date | November 10, 1999 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETA — Replacement, Ossicular Prosthesis, Total |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3495 |