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FDA 510(k)

MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM

K-Number: K021579 · 2002-08-09

ApplicantMagly Orthopedics, LLC
Decision Date2002-08-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Magly Orthopedics, LLC. It received FDA 510(k) clearance on 2002-08-09 under 510(k) number K021579. 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 MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM?

MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-09. The listed applicant is Magly Orthopedics, LLC. The 510(k) number is K021579.

When did MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM receive FDA 510(k) clearance?

MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM received FDA 510(k) clearance on 2002-08-09, under 510(k) number K021579.

Who is the listed applicant for MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM?

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

What is the FDA product code for MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM?

The FDA product code for MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Other records listing Magly Orthopedics, LLC 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.

K021662MAGLY 6.5MM CANNULATED SCREWSK020562APEX INTRAMEDULLARY NAIL 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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