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FDA 510(k)

GAMMA-BSM; BETA-BSM; EQUIVABONE

K-Number: K102812 · 2010-12-03

ApplicantEtex Corporation
Decision Date2010-12-03
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GAMMA-BSM; BETA-BSM; EQUIVABONE is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corporation. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K102812. 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 GAMMA-BSM; BETA-BSM; EQUIVABONE?

GAMMA-BSM; BETA-BSM; EQUIVABONE is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Etex Corporation. The 510(k) number is K102812.

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

GAMMA-BSM; BETA-BSM; EQUIVABONE received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102812.

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

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

What is the FDA product code for GAMMA-BSM; BETA-BSM; EQUIVABONE?

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

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Other records listing Etex Corporation 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.

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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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