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FDA 510(k)

MATRIX HA PEEK Cervical IBF System

K-Number: K232619 · 2024-03-19

ApplicantSapphire Medical Group
Decision Date2024-03-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MATRIX HA PEEK Cervical IBF System is a medical device manufactured by Sapphire Medical Group. It received FDA 510(k) clearance on 2024-03-19 under approval number K232619. 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 PEEK Cervical IBF System?

MATRIX HA PEEK Cervical IBF System is a medical device that received FDA 510(k) clearance on 2024-03-19. It is manufactured by Sapphire Medical Group. The 510(k) number is K232619.

When was MATRIX HA PEEK Cervical IBF System approved by the FDA?

MATRIX HA PEEK Cervical IBF System received FDA 510(k) clearance on 2024-03-19, under approval number K232619.

What company makes MATRIX HA PEEK Cervical IBF System?

MATRIX HA PEEK Cervical IBF System is manufactured by Sapphire Medical Group.

What is the FDA product code for MATRIX HA PEEK Cervical IBF System?

The FDA product code for MATRIX HA PEEK Cervical IBF System is ODP.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED 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 NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING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 Sapphire Medical Group

K172674Sapphire Cervical Implant System K192316Matrix HA PEEK Cervical Implant System K183073SMG Anterior Cervical Plate 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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