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FDA 510(k)

FUSION MEDICAL CANNULATED SCREW SYSTEM

K-Number: K081122 · 2009-05-26

ApplicantJohn Riccio
Decision Date2009-05-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUSION MEDICAL CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is John Riccio. It received FDA 510(k) clearance on 2009-05-26 under 510(k) number K081122. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSION MEDICAL CANNULATED SCREW SYSTEM?

FUSION MEDICAL CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-26. The listed applicant is John Riccio. The 510(k) number is K081122.

When did FUSION MEDICAL CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

FUSION MEDICAL CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2009-05-26, under 510(k) number K081122.

Who is the listed applicant for FUSION MEDICAL CANNULATED SCREW SYSTEM?

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

What is the FDA product code for FUSION MEDICAL CANNULATED SCREW SYSTEM?

The FDA product code for FUSION MEDICAL CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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Other records listing John Riccio 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.

K081755FUSION MEDICAL STI

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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