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FDA 510(k)

OSSATURA BCP BONE VOID FILLER

K-Number: K030131 · 2003-05-20

ApplicantIsotis NV
Decision Date2003-05-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSATURA BCP BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Isotis NV. It received FDA 510(k) clearance on 2003-05-20 under 510(k) number K030131. 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 OSSATURA BCP BONE VOID FILLER?

OSSATURA BCP BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Isotis NV. The 510(k) number is K030131.

When did OSSATURA BCP BONE VOID FILLER receive FDA 510(k) clearance?

OSSATURA BCP BONE VOID FILLER received FDA 510(k) clearance on 2003-05-20, under 510(k) number K030131.

Who is the listed applicant for OSSATURA BCP BONE VOID FILLER?

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

What is the FDA product code for OSSATURA BCP BONE VOID FILLER?

The FDA product code for OSSATURA BCP BONE VOID FILLER 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

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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