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FDA 510(k)

VERTICOR K-WIRE SYSTEM

K-Number: K110047 · 2011-02-28

Decision Date2011-02-28
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTICOR K-WIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Verticor, Ltd.. It received FDA 510(k) clearance on 2011-02-28 under 510(k) number K110047. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTICOR K-WIRE SYSTEM?

VERTICOR K-WIRE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-28. The listed applicant is Verticor, Ltd.. The 510(k) number is K110047.

When did VERTICOR K-WIRE SYSTEM receive FDA 510(k) clearance?

VERTICOR K-WIRE SYSTEM received FDA 510(k) clearance on 2011-02-28, under 510(k) number K110047.

Who is the listed applicant for VERTICOR K-WIRE SYSTEM?

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

What is the FDA product code for VERTICOR K-WIRE SYSTEM?

The FDA product code for VERTICOR K-WIRE SYSTEM is HTY.

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.

Other records listing Verticor, Ltd. 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.

Related Devices (Code: HTY)

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.

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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