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FDA 510(k)

CALCIGEN PSI BONE GRAFT SUBSTITUTE

K-Number: K032286 · 2003-11-20

ApplicantBiomet Orthopedics, Inc.
Decision Date2003-11-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALCIGEN PSI BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K032286. 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 CALCIGEN PSI BONE GRAFT SUBSTITUTE?

CALCIGEN PSI BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K032286.

When did CALCIGEN PSI BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

CALCIGEN PSI BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2003-11-20, under 510(k) number K032286.

Who is the listed applicant for CALCIGEN PSI BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for CALCIGEN PSI BONE GRAFT SUBSTITUTE?

The FDA product code for CALCIGEN PSI BONE GRAFT SUBSTITUTE is MQV.

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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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