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KURZ ANGULAR PISTON-TITANIUM PROSTHESIS - 1006 601

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010442

by Heinz Kurz

Identifiers

510(k) Number
K010442 FDA 510(k)
FDA Product Code
ETB FDA 510(k)
Models / Variants
1006 600 FDA 510(k)
1006 601 FDA 510(k)
1006 602 FDA 510(k)
1006 650 FDA 510(k)
1006 651 FDA 510(k)
1006 652 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3450 FDA 510(k)
Regulation Number
874.3450 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS - 1006 601 by Heinz Kurz — Class II — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Heinz Kurz

Sources (1)

  • FDA 510(k) K010442 24 fields · synced Jun 18, 2026