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FDA 510(k)

OsOpia Synthetic Bone Void Filler

K-Number: K201546 · 2020-10-02

ApplicantRevisios BV
Decision Date2020-10-02
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OsOpia Synthetic Bone Void Filler is a medical device manufactured by Revisios BV. It received FDA 510(k) clearance on 2020-10-02 under approval number K201546. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsOpia Synthetic Bone Void Filler?

OsOpia Synthetic Bone Void Filler is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Revisios BV. The 510(k) number is K201546.

When was OsOpia Synthetic Bone Void Filler approved by the FDA?

OsOpia Synthetic Bone Void Filler received FDA 510(k) clearance on 2020-10-02, under approval number K201546.

What company makes OsOpia Synthetic Bone Void Filler?

OsOpia Synthetic Bone Void Filler is manufactured by Revisios BV.

What is the FDA product code for OsOpia Synthetic Bone Void Filler?

The FDA product code for OsOpia Synthetic Bone Void Filler is LYC.

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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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