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FDA 510(k)

ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE

K-Number: K090850 · 2009-07-30

ApplicantApatech , Ltd.
Decision Date2009-07-30
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Apatech , Ltd.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K090850. 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 ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE?

ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Apatech , Ltd.. The 510(k) number is K090850.

When did ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2009-07-30, under 510(k) number K090850.

Who is the listed applicant for ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE?

The FDA product code for ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE is LYC.

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Other records listing Apatech , Ltd. 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.

K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTESK081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTEK082073ACTIFUSE FLOW BONE GRAFT SUBSTITUTEK080736ACTIFUSE SHAPE BONE GRAFT SUBSTITUTEK071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTEK040082PORE-SI BONE GRAFT SUBSTITUTE

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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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