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FDA 510(k)

CITIEFFE-TITANIUM CANNULATED SCREW

K-Number: K113388 · 2012-06-05

ApplicantCitieffe
Decision Date2012-06-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CITIEFFE-TITANIUM CANNULATED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K113388. 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 CITIEFFE-TITANIUM CANNULATED SCREW?

CITIEFFE-TITANIUM CANNULATED SCREW is a medical device that received FDA 510(k) clearance on 2012-06-05. The listed applicant is Citieffe. The 510(k) number is K113388.

When did CITIEFFE-TITANIUM CANNULATED SCREW receive FDA 510(k) clearance?

CITIEFFE-TITANIUM CANNULATED SCREW received FDA 510(k) clearance on 2012-06-05, under 510(k) number K113388.

Who is the listed applicant for CITIEFFE-TITANIUM CANNULATED SCREW?

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

What is the FDA product code for CITIEFFE-TITANIUM CANNULATED SCREW?

The FDA product code for CITIEFFE-TITANIUM CANNULATED SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Other records listing Citieffe 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.

K113384EXTERNAL FIXATOR ST.A R 90 F4K113387CITIEFFE TITANIUM NAILING SYSTEM

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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