The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Zurich Titanium Ossicular Replacement System.
| Device ID | K993583 |
| 510k Number | K993583 |
| Device Name: | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 1999-11-10 |
| Summary: | summary |