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FDA 510(k)

MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)

K-Number: K091694 · 2009-07-07

ApplicantTag Medical Products
Decision Date2009-07-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) 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 2009-07-07 under 510(k) number K091694. 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 MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)?

MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) is a medical device that received FDA 510(k) clearance on 2009-07-07. The listed applicant is Tag Medical Products. The 510(k) number is K091694.

When did MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) receive FDA 510(k) clearance?

MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) received FDA 510(k) clearance on 2009-07-07, under 510(k) number K091694.

Who is the listed applicant for MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)?

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 MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)?

The FDA product code for MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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 TRAYK083096LATARJET CORTICAL SCREW SETK020705SIIS#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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