REL-K ARTIFICAL LIMB PROSTHESIS— 510(k) K101859

Name: FDA 510(k) clearance K101859
Creator: U.S. Food and Drug Administration
Published: 2010-10-13

Substantially Equivalent

Rizzoli Ortopedica S.P.A.

FDA 510(k) clearance K101859 for REL-K ARTIFICAL LIMB PROSTHESIS, Substantially Equivalent on 2010-10-13. Applicant: Rizzoli Ortopedica S.P.A.. Device class: 1.

Clearance details

Applicant: Rizzoli Ortopedica S.P.A.
Product code: Code ISY
Device class: Class 1
Regulation: 21 CFR 890.3420
Advisory panel: Physical Medicine
Date received: 2010-07-02
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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