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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 a medical device manufactured by Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2020-10-22 under approval 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. It is manufactured by Gramercy Extremity Orthopedics, LLC. The 510(k) number is K202817.

When was GEO Bone Screw System approved by the FDA?

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

What company makes GEO Bone Screw System?

GEO Bone Screw System is manufactured by Gramercy Extremity Orthopedics, LLC.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Gramercy Extremity Orthopedics, LLC

K182212Geo Staple System K200108GEO 1st MTP Joint Arthrodesis Plating System K212334GEO Extremity and Ankle Plating System K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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