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FDA 510(k)

ARROWBONE-A, ARROWBONE-B

K-Number: K083372 · 2009-12-08

ApplicantBrainbase Corporation
Decision Date2009-12-08
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARROWBONE-A, ARROWBONE-B is the device name listed in this FDA 510(k) record. The listed applicant is Brainbase Corporation. It received FDA 510(k) clearance on 2009-12-08 under 510(k) number K083372. 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 ARROWBONE-A, ARROWBONE-B?

ARROWBONE-A, ARROWBONE-B is a medical device that received FDA 510(k) clearance on 2009-12-08. The listed applicant is Brainbase Corporation. The 510(k) number is K083372.

When did ARROWBONE-A, ARROWBONE-B receive FDA 510(k) clearance?

ARROWBONE-A, ARROWBONE-B received FDA 510(k) clearance on 2009-12-08, under 510(k) number K083372.

Who is the listed applicant for ARROWBONE-A, ARROWBONE-B?

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

What is the FDA product code for ARROWBONE-A, ARROWBONE-B?

The FDA product code for ARROWBONE-A, ARROWBONE-B is LYC.

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Other records listing Brainbase 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.

K063236BETA-POWDERK052254MYTIS ARROW XXXX

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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