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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 the device name listed in this FDA 510(k) record. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. It received FDA 510(k) clearance on 2018-10-11 under 510(k) 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. The listed applicant is Matrix Surgical Holdings, LLC/Matrix Surgical USA. The 510(k) number is K180249.

When did OmniPore DUROMAX Surgical Implants receive FDA 510(k) clearance?

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

Who is the listed applicant for OmniPore DUROMAX Surgical Implants?

The FDA 510(k) record lists Matrix Surgical Holdings, LLC/Matrix Surgical USA as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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