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FDA 510(k)

OSTEOPORE PCL SCAFFOLD

K-Number: K051093 · 2006-03-17

ApplicantOsteopore, Inc.
Decision Date2006-03-17
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOPORE PCL SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Osteopore, Inc.. It received FDA 510(k) clearance on 2006-03-17 under 510(k) number K051093. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOPORE PCL SCAFFOLD?

OSTEOPORE PCL SCAFFOLD is a medical device that received FDA 510(k) clearance on 2006-03-17. The listed applicant is Osteopore, Inc.. The 510(k) number is K051093.

When did OSTEOPORE PCL SCAFFOLD receive FDA 510(k) clearance?

OSTEOPORE PCL SCAFFOLD received FDA 510(k) clearance on 2006-03-17, under 510(k) number K051093.

Who is the listed applicant for OSTEOPORE PCL SCAFFOLD?

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

What is the FDA product code for OSTEOPORE PCL SCAFFOLD?

The FDA product code for OSTEOPORE PCL SCAFFOLD is GXP.

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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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