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FDA 510(k)

CONNEXUS

K-Number: K050690 · 2005-07-07

ApplicantIsotis Orthobiologics, Inc.
Decision Date2005-07-07
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONNEXUS is the device name listed in this FDA 510(k) record. The listed applicant is Isotis Orthobiologics, Inc.. It received FDA 510(k) clearance on 2005-07-07 under 510(k) number K050690. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNEXUS?

CONNEXUS is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Isotis Orthobiologics, Inc.. The 510(k) number is K050690.

When did CONNEXUS receive FDA 510(k) clearance?

CONNEXUS received FDA 510(k) clearance on 2005-07-07, under 510(k) number K050690.

Who is the listed applicant for CONNEXUS?

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

What is the FDA product code for CONNEXUS?

The FDA product code for CONNEXUS is MQV.

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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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