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FDA 510(k)

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2

K-Number: K013903 · 2001-12-17

ApplicantTriad Medical, Inc.
Decision Date2001-12-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 is the device name listed in this FDA 510(k) record. The listed applicant is Triad Medical, Inc.. It received FDA 510(k) clearance on 2001-12-17 under 510(k) number K013903. 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 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2?

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 is a medical device that received FDA 510(k) clearance on 2001-12-17. The listed applicant is Triad Medical, Inc.. The 510(k) number is K013903.

When did HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 receive FDA 510(k) clearance?

HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 received FDA 510(k) clearance on 2001-12-17, under 510(k) number K013903.

Who is the listed applicant for HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2?

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

What is the FDA product code for HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2?

The FDA product code for HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 is HWC. This falls under the Cardiovascular category.

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Other records listing Triad Medical, 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.

K022647HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM

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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