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FDA 510(k)

FM-02 BONE GRAFT SUBSTITUTE

K-Number: K102545 · 2010-10-27

ApplicantOrthovita, Inc.
Decision Date2010-10-27
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FM-02 BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2010-10-27 under 510(k) number K102545. 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 FM-02 BONE GRAFT SUBSTITUTE?

FM-02 BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Orthovita, Inc.. The 510(k) number is K102545.

When did FM-02 BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

FM-02 BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2010-10-27, under 510(k) number K102545.

Who is the listed applicant for FM-02 BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for FM-02 BONE GRAFT SUBSTITUTE?

The FDA product code for FM-02 BONE GRAFT SUBSTITUTE is MQV.

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Other records listing Orthovita, Inc. as applicant

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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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