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FDA 510(k)

BIOACTYS

K-Number: K082286 · 2009-02-24

ApplicantGraftys
Decision Date2009-02-24
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOACTYS is the device name listed in this FDA 510(k) record. The listed applicant is Graftys. It received FDA 510(k) clearance on 2009-02-24 under 510(k) number K082286. 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 BIOACTYS?

BIOACTYS is a medical device that received FDA 510(k) clearance on 2009-02-24. The listed applicant is Graftys. The 510(k) number is K082286.

When did BIOACTYS receive FDA 510(k) clearance?

BIOACTYS received FDA 510(k) clearance on 2009-02-24, under 510(k) number K082286.

Who is the listed applicant for BIOACTYS?

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

What is the FDA product code for BIOACTYS?

The FDA product code for BIOACTYS is LYC.

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Other records listing Graftys 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.

K231714Graftys QuicksetK093343GRAFTY QUICKSETK082498GRAFTYS HBSK073064GRAFTYS BCP

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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