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FDA 510(k)

OmniPore DUROMAX Surgical Implants

K-Number: K180249 · 2018-10-11

ApplicantMatrix Surgical Holdings, LLC/Matrix Surgical USA
Decision Date2018-10-11
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OmniPore DUROMAX Surgical Implants is a medical device manufactured by Matrix Surgical Holdings, LLC/Matrix Surgical USA. It received FDA 510(k) clearance on 2018-10-11 under approval number K180249. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniPore DUROMAX Surgical Implants?

OmniPore DUROMAX Surgical Implants is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Matrix Surgical Holdings, LLC/Matrix Surgical USA. The 510(k) number is K180249.

When was OmniPore DUROMAX Surgical Implants approved by the FDA?

OmniPore DUROMAX Surgical Implants received FDA 510(k) clearance on 2018-10-11, under approval number K180249.

What company makes OmniPore DUROMAX Surgical Implants?

OmniPore DUROMAX Surgical Implants is manufactured by Matrix Surgical Holdings, LLC/Matrix Surgical USA.

What is the FDA product code for OmniPore DUROMAX Surgical Implants?

The FDA product code for OmniPore DUROMAX Surgical Implants is JEY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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