510(k) K101859

Device: REL-K ARTIFICAL LIMB PROSTHESIS
Applicant: Rizzoli Ortopedica S.P.A.
510(k) number: K101859
Product code: ISY
Decision: Substantially Equivalent (SESE)
Decision date: 2010-10-13
Date received: 2010-07-02
Regulation: 890.3420
Classification name: Joint, Knee, External Limb Component
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DIANE C TIERNAN, MS RAC
Address: 58a Bates Rd. Watertown MA US 02472 02472

FDA Registration Numbers#

Source Documents#

510(k) summary PDF