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FDA 510(k)

SYNTHOGRAFT

K-Number: K051091 · 2005-09-01

ApplicantBicon, Inc.
Decision Date2005-09-01
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHOGRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, Inc.. It received FDA 510(k) clearance on 2005-09-01 under 510(k) number K051091. 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 SYNTHOGRAFT?

SYNTHOGRAFT is a medical device that received FDA 510(k) clearance on 2005-09-01. The listed applicant is Bicon, Inc.. The 510(k) number is K051091.

When did SYNTHOGRAFT receive FDA 510(k) clearance?

SYNTHOGRAFT received FDA 510(k) clearance on 2005-09-01, under 510(k) number K051091.

Who is the listed applicant for SYNTHOGRAFT?

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

What is the FDA product code for SYNTHOGRAFT?

The FDA product code for SYNTHOGRAFT is LYC.

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Other records listing Bicon, Inc. 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.

K062044THE 5.0 X 6.0MM DENTAL IMPLANTK0507124.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANTK050408BICON ORTHODONTIC IMPLANT SYSTEMK031568BICONITE SURFACE TREATMENTK042637THE 5.0 X 6.0MM DENTAL IMPLANTK023705BICON TRANSITIONAL IMPLANT (BTI) SYSTEM

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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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