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FDA 510(k)

FUSION

K-Number: K061557 · 2006-09-15

ApplicantMedwave, Inc.
Decision Date2006-09-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUSION is the device name listed in this FDA 510(k) record. The listed applicant is Medwave, Inc.. It received FDA 510(k) clearance on 2006-09-15 under 510(k) number K061557. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSION?

FUSION is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Medwave, Inc.. The 510(k) number is K061557.

When did FUSION receive FDA 510(k) clearance?

FUSION received FDA 510(k) clearance on 2006-09-15, under 510(k) number K061557.

Who is the listed applicant for FUSION?

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

What is the FDA product code for FUSION?

The FDA product code for FUSION is DXN.

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Related PubMed Literature

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.

PMID: 37504879Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery.Journal of functional biomaterials ()PMID: 34249562Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion.Cureus ()PMID: 33778409Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices.JOR spine ()PMID: 28256243Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.Journal of biomechanics ()

Other records listing Medwave, Inc. as applicant

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.

K053185PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEMK011152VASOTRAC APM205AK001898VASOTRAXK950249VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205

Related Devices (Code: DXN)

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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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