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FDA 510(k)

Matrix HA PEEK Cervical Implant System

K-Number: K192316 · 2019-10-17

ApplicantSapphire Medical Group
Decision Date2019-10-17
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Matrix HA PEEK Cervical Implant System is a medical device manufactured by Sapphire Medical Group. It received FDA 510(k) clearance on 2019-10-17 under approval number K192316. 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 Implant System?

Matrix HA PEEK Cervical Implant System is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Sapphire Medical Group. The 510(k) number is K192316.

When was Matrix HA PEEK Cervical Implant System approved by the FDA?

Matrix HA PEEK Cervical Implant System received FDA 510(k) clearance on 2019-10-17, under approval number K192316.

What company makes Matrix HA PEEK Cervical Implant System?

Matrix HA PEEK Cervical Implant System is manufactured by Sapphire Medical Group.

What is the FDA product code for Matrix HA PEEK Cervical Implant System?

The FDA product code for Matrix HA PEEK Cervical Implant System is ODP.

Related Clinical Trials

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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) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Sapphire Medical Group

K172674Sapphire Cervical Implant System K183073SMG Anterior Cervical Plate System K232619MATRIX HA PEEK Cervical IBF 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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