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FDA 510(k)

GEO Bone Screw System

K-Number: K202817 · 2020-10-22

ApplicantGramercy Extremity Orthopedics, LLC
Decision Date2020-10-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEO Bone Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K202817. 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 GEO Bone Screw System?

GEO Bone Screw System is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K202817.

When did GEO Bone Screw System receive FDA 510(k) clearance?

GEO Bone Screw System received FDA 510(k) clearance on 2020-10-22, under 510(k) number K202817.

Who is the listed applicant for GEO Bone Screw System?

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

What is the FDA product code for GEO Bone Screw System?

The FDA product code for GEO Bone Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Gramercy Extremity Orthopedics, LLC as applicant

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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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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