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FDA 510(k)

MONSTER SCREW SYSTEM

K-Number: K124027 · 2013-04-05

ApplicantApogee Orthosolutions
Decision Date2013-04-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONSTER SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apogee Orthosolutions. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K124027. 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 MONSTER SCREW SYSTEM?

MONSTER SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Apogee Orthosolutions. The 510(k) number is K124027.

When did MONSTER SCREW SYSTEM receive FDA 510(k) clearance?

MONSTER SCREW SYSTEM received FDA 510(k) clearance on 2013-04-05, under 510(k) number K124027.

Who is the listed applicant for MONSTER SCREW SYSTEM?

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

What is the FDA product code for MONSTER SCREW SYSTEM?

The FDA product code for MONSTER SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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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