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FDA 510(k)

Resorbable Mesh Device

K-Number: K193040 · 2019-11-30

ApplicantSeaSpine Orthopedics Corporation
Decision Date2019-11-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Resorbable Mesh Device is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-11-30 under 510(k) number K193040. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resorbable Mesh Device?

Resorbable Mesh Device is a medical device that received FDA 510(k) clearance on 2019-11-30. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K193040.

When did Resorbable Mesh Device receive FDA 510(k) clearance?

Resorbable Mesh Device received FDA 510(k) clearance on 2019-11-30, under 510(k) number K193040.

Who is the listed applicant for Resorbable Mesh Device?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resorbable Mesh Device?

The FDA product code for Resorbable Mesh Device is MQV.

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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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