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FDA 510(k)

REL-K ARTIFICAL LIMB PROSTHESIS

K-Number: K101859 · 2010-10-13

ApplicantRizzoli Ortopedica S.P.A.
Decision Date2010-10-13
Product CodeISY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REL-K ARTIFICAL LIMB PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Rizzoli Ortopedica S.P.A.. It received FDA 510(k) clearance on 2010-10-13 under 510(k) number K101859. The device is classified under product code ISY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REL-K ARTIFICAL LIMB PROSTHESIS?

REL-K ARTIFICAL LIMB PROSTHESIS is a medical device that received FDA 510(k) clearance on 2010-10-13. The listed applicant is Rizzoli Ortopedica S.P.A.. The 510(k) number is K101859.

When did REL-K ARTIFICAL LIMB PROSTHESIS receive FDA 510(k) clearance?

REL-K ARTIFICAL LIMB PROSTHESIS received FDA 510(k) clearance on 2010-10-13, under 510(k) number K101859.

Who is the listed applicant for REL-K ARTIFICAL LIMB PROSTHESIS?

The FDA 510(k) record lists Rizzoli Ortopedica S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REL-K ARTIFICAL LIMB PROSTHESIS?

The FDA product code for REL-K ARTIFICAL LIMB PROSTHESIS is ISY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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