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FDA 510(k)

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

K-Number: K200290 · 2020-05-11

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-05-11
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) 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 2020-05-11 under 510(k) number K200290. 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 Pouch (Ballast MT, OsteoBallast MT)?

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K200290.

When did Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) receive FDA 510(k) clearance?

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200290.

Who is the listed applicant for Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)?

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 Pouch (Ballast MT, OsteoBallast MT)?

The FDA product code for Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) 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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