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FDA 510(k)

MATISSE Anterior Cervical Interbody Fusion Cage System

K-Number: K162682 · 2017-06-01

ApplicantCtl Medical Corporation
Decision Date2017-06-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATISSE Anterior Cervical Interbody Fusion Cage System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2017-06-01 under approval number K162682. 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 MATISSE Anterior Cervical Interbody Fusion Cage System?

MATISSE Anterior Cervical Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Ctl Medical Corporation. The 510(k) number is K162682.

When was MATISSE Anterior Cervical Interbody Fusion Cage System approved by the FDA?

MATISSE Anterior Cervical Interbody Fusion Cage System received FDA 510(k) clearance on 2017-06-01, under approval number K162682.

What company makes MATISSE Anterior Cervical Interbody Fusion Cage System?

MATISSE Anterior Cervical Interbody Fusion Cage System is manufactured by Ctl Medical Corporation.

What is the FDA product code for MATISSE Anterior Cervical Interbody Fusion Cage System?

The FDA product code for MATISSE Anterior Cervical Interbody Fusion Cage System is ODP.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING 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 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 NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 28256243 Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration. Journal of biomechanics (2017)

Other Devices by Ctl Medical Corporation

K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K172788MONET™ Anterior Cervical Interbody Fusion Cage System K173185SEURAT™ Universal Pedicle Screw System K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ K192863MONDRIAN Lumbar Interbody Fusion Cage System K220334MONET Anterior Cervical Plate System

View all 14 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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