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FDA 510(k)

ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM

K-Number: K102324 · 2011-05-04

ApplicantWrightmedicaltechnologyinc
Decision Date2011-05-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2011-05-04 under 510(k) number K102324. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM?

ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-04. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K102324.

When did ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM receive FDA 510(k) clearance?

ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM received FDA 510(k) clearance on 2011-05-04, under 510(k) number K102324.

Who is the listed applicant for ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM?

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

What is the FDA product code for ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM?

The FDA product code for ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM is HWC. This falls under the Cardiovascular category.

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Official Source

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