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FDA 510(k)

SYNERGY CANNULATED SCREW SYSTEM

K-Number: K092082 · 2009-10-02

ApplicantSynergy Surgical Technologies, LLC
Decision Date2009-10-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNERGY CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synergy Surgical Technologies, LLC. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K092082. 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 SYNERGY CANNULATED SCREW SYSTEM?

SYNERGY CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Synergy Surgical Technologies, LLC. The 510(k) number is K092082.

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

SYNERGY CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2009-10-02, under 510(k) number K092082.

Who is the listed applicant for SYNERGY CANNULATED SCREW SYSTEM?

The FDA 510(k) record lists Synergy Surgical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERGY CANNULATED SCREW SYSTEM?

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

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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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