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FDA 510(k)

LATARJET CORTICAL SCREW SET

K-Number: K110763 · 2011-04-11

ApplicantT.A.G. Medical Products Corporation, Ltd.
Decision Date2011-04-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATARJET CORTICAL SCREW SET is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2011-04-11 under 510(k) number K110763. 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 LATARJET CORTICAL SCREW SET?

LATARJET CORTICAL SCREW SET is a medical device that received FDA 510(k) clearance on 2011-04-11. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K110763.

When did LATARJET CORTICAL SCREW SET receive FDA 510(k) clearance?

LATARJET CORTICAL SCREW SET received FDA 510(k) clearance on 2011-04-11, under 510(k) number K110763.

Who is the listed applicant for LATARJET CORTICAL SCREW SET?

The FDA 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATARJET CORTICAL SCREW SET?

The FDA product code for LATARJET CORTICAL SCREW SET is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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