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FDA 510(k)

SI-FIX SACROILIAC JOINT FUSION SYSTEM

K-Number: K110472 · 2012-05-29

ApplicantMedtronic Sofamor Danek
Decision Date2012-05-29
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-FIX SACROILIAC JOINT FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2012-05-29 under 510(k) number K110472. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-FIX SACROILIAC JOINT FUSION SYSTEM?

SI-FIX SACROILIAC JOINT FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-29. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K110472.

When did SI-FIX SACROILIAC JOINT FUSION SYSTEM receive FDA 510(k) clearance?

SI-FIX SACROILIAC JOINT FUSION SYSTEM received FDA 510(k) clearance on 2012-05-29, under 510(k) number K110472.

Who is the listed applicant for SI-FIX SACROILIAC JOINT FUSION SYSTEM?

The FDA 510(k) record lists Medtronic Sofamor Danek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SI-FIX SACROILIAC JOINT FUSION SYSTEM?

The FDA product code for SI-FIX SACROILIAC JOINT FUSION SYSTEM is OUR.

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Official Source

View on FDA Database →

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

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