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FDA 510(k)

UNIGRAFT

K-Number: K003457 · 2001-01-09

ApplicantUnicare Biomedical
Decision Date2001-01-09
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIGRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Unicare Biomedical. It received FDA 510(k) clearance on 2001-01-09 under 510(k) number K003457. 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 UNIGRAFT?

UNIGRAFT is a medical device that received FDA 510(k) clearance on 2001-01-09. The listed applicant is Unicare Biomedical. The 510(k) number is K003457.

When did UNIGRAFT receive FDA 510(k) clearance?

UNIGRAFT received FDA 510(k) clearance on 2001-01-09, under 510(k) number K003457.

Who is the listed applicant for UNIGRAFT?

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

What is the FDA product code for UNIGRAFT?

The FDA product code for UNIGRAFT is LYC.

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Other records listing Unicare Biomedical 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.

K090612BENACELK993784UNIGRAFTK982699UNIGRAFE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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