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FDA 510(k)

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

K-Number: K101557 · 2010-07-01

ApplicantEtex Corp.
Decision Date2010-07-01
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K101557. 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 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN?

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Etex Corp.. The 510(k) number is K101557.

When did GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN receive FDA 510(k) clearance?

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN received FDA 510(k) clearance on 2010-07-01, under 510(k) number K101557.

Who is the listed applicant for GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN?

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 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN?

The FDA product code for GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN is MQV.

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Other records listing Etex Corp. as applicant

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.

K100883CARRIGENK093447CARRIGENK091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTEK090310EQUIVABONE

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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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