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FDA 510(k)

LATARJET CORTICAL SCREW SET

K-Number: K083096 · 2009-04-17

ApplicantTag Medical Products
Decision Date2009-04-17
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 Tag Medical Products. It received FDA 510(k) clearance on 2009-04-17 under 510(k) number K083096. 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 2009-04-17. The listed applicant is Tag Medical Products. The 510(k) number is K083096.

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

LATARJET CORTICAL SCREW SET received FDA 510(k) clearance on 2009-04-17, under 510(k) number K083096.

Who is the listed applicant for LATARJET CORTICAL SCREW SET?

The FDA 510(k) record lists Tag Medical Products 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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Other records listing Tag Medical Products 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.

K100887VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAYK091694MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)K020705SIIS#1 TISSUE SUSPENSION 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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