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FDA 510(k)

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM

K-Number: K101254 · 2010-07-15

ApplicantTecnologia Y Diseno Industrial, S.A DE C.V
Decision Date2010-07-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tecnologia Y Diseno Industrial, S.A DE C.V. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K101254. 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 NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM?

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Tecnologia Y Diseno Industrial, S.A DE C.V. The 510(k) number is K101254.

When did NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM receive FDA 510(k) clearance?

NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM received FDA 510(k) clearance on 2010-07-15, under 510(k) number K101254.

Who is the listed applicant for NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM?

The FDA 510(k) record lists Tecnologia Y Diseno Industrial, S.A DE C.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM?

The FDA product code for NEWFIX SCREW, WIRE AND PIN FIXARION 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 Tecnologia Y Diseno Industrial, S.A DE C.V 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.

K122210NEWFIX EXTERNAL FIXATION 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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