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FDA 510(k)

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

K-Number: K091729 · 2009-12-23

ApplicantEtex Corp.
Decision Date2009-12-23
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K091729. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE?

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Etex Corp.. The 510(k) number is K091729.

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

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE received FDA 510(k) clearance on 2009-12-23, under 510(k) number K091729.

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

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 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE?

The FDA product code for ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE is LYC.

Related Clinical Trials

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.

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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.

K100883CARRIGENK101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENK093447CARRIGENK091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTEK090310EQUIVABONE

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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