510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112616Substantially Equivalent

Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis

Heinz Kurz GmbH Medizintechnik, Amsterdam, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112616 is the FDA 510(k) clearance record for NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS, a class II device, cleared for Heinz Kurz GmbH Medizintechnik on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list 14 510(k) clearances for Heinz Kurz GmbH Medizintechnik, from to . As of , FDA records show no recalls naming K112616.

Clearance record

Decision date
Received
(519 days to decision)
Product code
ETB Prosthesis, Partial Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Heinz Kurz GmbH Medizintechnik Amstel 320-1, Amsterdam, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETB

Trailing 12 months
2 clearances under product code ETB in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260