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FDA 510(k)

HEALOS BONE GRAFT MATERIAL

K-Number: K012751 · 2001-11-14

ApplicantOrquest, Inc.
Decision Date2001-11-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALOS BONE GRAFT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Orquest, Inc.. It received FDA 510(k) clearance on 2001-11-14 under 510(k) number K012751. 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 BONE GRAFT MATERIAL?

HEALOS BONE GRAFT MATERIAL is a medical device that received FDA 510(k) clearance on 2001-11-14. The listed applicant is Orquest, Inc.. The 510(k) number is K012751.

When did HEALOS BONE GRAFT MATERIAL receive FDA 510(k) clearance?

HEALOS BONE GRAFT MATERIAL received FDA 510(k) clearance on 2001-11-14, under 510(k) number K012751.

Who is the listed applicant for HEALOS BONE GRAFT MATERIAL?

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

What is the FDA product code for HEALOS BONE GRAFT MATERIAL?

The FDA product code for HEALOS BONE GRAFT MATERIAL 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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