Zurich Titanium Ossicular Replacement System
FDA 510(k) K993583 · Stryker Corp.
510(k) numberK993583
Submission
- Device name
- Zurich Titanium Ossicular Replacement System
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- October 22, 1999
- Decision date
- November 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETA – Replacement, Ossicular Prosthesis, Total
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3495
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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| K001404 | Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total…ETA · Traditional | Mednet Locator, Inc. | 08/08/2000SE |
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Questions and answers
When was Zurich Titanium Ossicular Replacement System cleared by the FDA?
Zurich Titanium Ossicular Replacement System (K993583) received a 510(k) decision of Substantially Equivalent on November 10, 1999, 19 days after the submission was received.
What is the product code of K993583?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.