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FDA 510(k)

HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM

K-Number: K062495 · 2006-10-13

ApplicantDepuy Spine, Inc.
Decision Date2006-10-13
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K062495. 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 HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM?

HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K062495.

When did HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM receive FDA 510(k) clearance?

HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062495.

Who is the listed applicant for HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM?

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

What is the FDA product code for HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM?

The FDA product code for HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM is MQV.

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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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