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FDA 510(k)

CAP PLUS, EQUIVABONE, CAP/DBM

K-Number: K080329 · 2008-04-28

ApplicantEtex Corp.
Decision Date2008-04-28
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAP PLUS, EQUIVABONE, CAP/DBM is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2008-04-28 under 510(k) number K080329. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAP PLUS, EQUIVABONE, CAP/DBM?

CAP PLUS, EQUIVABONE, CAP/DBM is a medical device that received FDA 510(k) clearance on 2008-04-28. The listed applicant is Etex Corp.. The 510(k) number is K080329.

When did CAP PLUS, EQUIVABONE, CAP/DBM receive FDA 510(k) clearance?

CAP PLUS, EQUIVABONE, CAP/DBM received FDA 510(k) clearance on 2008-04-28, under 510(k) number K080329.

Who is the listed applicant for CAP PLUS, EQUIVABONE, CAP/DBM?

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

What is the FDA product code for CAP PLUS, EQUIVABONE, CAP/DBM?

The FDA product code for CAP PLUS, EQUIVABONE, CAP/DBM is MBP.

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Other records listing Etex Corp. as applicant

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K100883CARRIGENK101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENK093447CARRIGENK091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

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K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences

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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