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FDA 510(k)

Gemini Cervical Fusion Cage System

K-Number: K242195 · 2024-11-04

ApplicantZheJiang Decans Medical Devices Co., Ltd.
Decision Date2024-11-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gemini Cervical Fusion Cage System is a medical device manufactured by ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-11-04 under approval number K242195. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gemini Cervical Fusion Cage System?

Gemini Cervical Fusion Cage System is a medical device that received FDA 510(k) clearance on 2024-11-04. It is manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K242195.

When was Gemini Cervical Fusion Cage System approved by the FDA?

Gemini Cervical Fusion Cage System received FDA 510(k) clearance on 2024-11-04, under approval number K242195.

What company makes Gemini Cervical Fusion Cage System?

Gemini Cervical Fusion Cage System is manufactured by ZheJiang Decans Medical Devices Co., Ltd..

What is the FDA product code for Gemini Cervical Fusion Cage System?

The FDA product code for Gemini Cervical Fusion Cage System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT06907147 SPYRAL GEMINI Pilot Study RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Other Devices by ZheJiang Decans Medical Devices Co., Ltd.

K242267Gemini Medical Cage System K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) K252776ARIES Anterior Cervical Plate Systems K252542LEO Spinal System K253213SAGI Cervical Cage System K252774Uni-C Cervical Cage System

View all 7 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, 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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