FDA 510(k)

GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE

K-Number: K051267 · 2005-06-15

Decision Date2005-06-15

Product CodeNPK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2005-06-15 under 510(k) number K051267. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE?

GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE is a medical device that received FDA 510(k) clearance on 2005-06-15. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K051267.

When did GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE receive FDA 510(k) clearance?

GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE received FDA 510(k) clearance on 2005-06-15, under 510(k) number K051267.

Who is the listed applicant for GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE?

The FDA product code for GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE is NPK.

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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.