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FDA 510(k)

FRACTORA

K-Number: K102461 · 2011-06-02

ApplicantInvasix , Ltd.
Decision Date2011-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRACTORA is the device name listed in this FDA 510(k) record. The listed applicant is Invasix , Ltd.. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K102461. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRACTORA?

FRACTORA is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Invasix , Ltd.. The 510(k) number is K102461.

When did FRACTORA receive FDA 510(k) clearance?

FRACTORA received FDA 510(k) clearance on 2011-06-02, under 510(k) number K102461.

Who is the listed applicant for FRACTORA?

The FDA 510(k) record lists Invasix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRACTORA?

The FDA product code for FRACTORA is GEI.

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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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