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FDA 510(k)

Summit Spine Channel Cervical Interbody Fusion System

K-Number: K163494 · 2017-06-20

ApplicantSummit Spine
Decision Date2017-06-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Summit Spine Channel Cervical Interbody Fusion System is a medical device manufactured by Summit Spine. It received FDA 510(k) clearance on 2017-06-20 under approval number K163494. 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 Summit Spine Channel Cervical Interbody Fusion System?

Summit Spine Channel Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-06-20. It is manufactured by Summit Spine. The 510(k) number is K163494.

When was Summit Spine Channel Cervical Interbody Fusion System approved by the FDA?

Summit Spine Channel Cervical Interbody Fusion System received FDA 510(k) clearance on 2017-06-20, under approval number K163494.

What company makes Summit Spine Channel Cervical Interbody Fusion System?

Summit Spine Channel Cervical Interbody Fusion System is manufactured by Summit Spine.

What is the FDA product code for Summit Spine Channel Cervical Interbody Fusion System?

The FDA product code for Summit Spine Channel Cervical Interbody Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

Other Devices by Summit Spine

K170572Summit Spine Yellowstone Lumbar Interbody Fusion System

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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