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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 a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-05-11 under approval 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. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K200290.

When was Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) approved by the FDA?

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

What company makes Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)?

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) is manufactured by SeaSpine Orthopedics Corporation.

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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