510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K993583Substantially Equivalent

Zurich Titanium Ossicular Replacement System

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993583 is the FDA 510(k) clearance record for ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM, a class II device, cleared for Stryker Corp. on under FDA product code ETA (Replacement, Ossicular Prosthesis, Total). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K993583.

Clearance record

Decision date
Received
(19 days to decision)
Product code
ETA Replacement, Ossicular Prosthesis, Total
Regulation
21 CFR 874.3495
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Stryker Corp. 4100 E. Milham Ave., Kalamazoo MI
510(k) summary
Summary
Third party review
No

Clearances, product code ETA

Trailing 12 months
2 clearances under product code ETA in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260