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FDA 510(k)

Matrix HA Fusion Porous Cervical IBF System

K-Number: K223510 · 2022-12-12

ApplicantInnovasis, Inc.
Decision Date2022-12-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Matrix HA Fusion Porous Cervical IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2022-12-12 under approval number K223510. 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 Matrix HA Fusion Porous Cervical IBF System?

Matrix HA Fusion Porous Cervical IBF System is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by Innovasis, Inc.. The 510(k) number is K223510.

When was Matrix HA Fusion Porous Cervical IBF System approved by the FDA?

Matrix HA Fusion Porous Cervical IBF System received FDA 510(k) clearance on 2022-12-12, under approval number K223510.

What company makes Matrix HA Fusion Porous Cervical IBF System?

Matrix HA Fusion Porous Cervical IBF System is manufactured by Innovasis, Inc..

What is the FDA product code for Matrix HA Fusion Porous Cervical IBF System?

The FDA product code for Matrix HA Fusion Porous Cervical IBF 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 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 NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Innovasis, Inc.

K162143FixxSure® X-Link K162236Ax Stand-Alone ALIF System K181115CxHA PEEK Cervical IBF System K181063Kestrel™ Buttress Plate System K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System K192049Oryx Cervical Plate System

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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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