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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 the device name listed in this FDA 510(k) record. The listed applicant is Revisios BV. It received FDA 510(k) clearance on 2020-10-02 under 510(k) 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. The listed applicant is Revisios BV. The 510(k) number is K201546.

When did OsOpia Synthetic Bone Void Filler receive FDA 510(k) clearance?

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

Who is the listed applicant for OsOpia Synthetic Bone Void Filler?

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

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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Related Devices (Code: LYC)

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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