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FDA 510(k)

MODIFICATION TO: HEALOS BONE GRAFT MATERIAL

K-Number: K043308 · 2005-02-16

ApplicantDepuy Spine, Inc.
Decision Date2005-02-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: HEALOS BONE GRAFT MATERIAL 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 2005-02-16 under 510(k) number K043308. 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 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL?

MODIFICATION TO: HEALOS BONE GRAFT MATERIAL is a medical device that received FDA 510(k) clearance on 2005-02-16. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K043308.

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

MODIFICATION TO: HEALOS BONE GRAFT MATERIAL received FDA 510(k) clearance on 2005-02-16, under 510(k) number K043308.

Who is the listed applicant for MODIFICATION TO: HEALOS BONE GRAFT MATERIAL?

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 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL?

The FDA product code for MODIFICATION TO: HEALOS BONE GRAFT MATERIAL is MQV.

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Other records listing Depuy Spine, Inc. as applicant

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Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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