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FDA 510(k)

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

K-Number: K090177 · 2009-02-20

ApplicantInion OY
Decision Date2009-02-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K090177. 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 INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE?

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Inion OY. The 510(k) number is K090177.

When did INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2009-02-20, under 510(k) number K090177.

Who is the listed applicant for INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE?

The FDA product code for INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE is MQV.

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Related Devices (Code: MQV)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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