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FDA 510(k)

OSTEOGRAFT/N-700 HYDROXYLAPTITE

K-Number: K960368 · 1996-04-18

ApplicantCeramed Corp.
Decision Date1996-04-18
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAFT/N-700 HYDROXYLAPTITE is the device name listed in this FDA 510(k) record. The listed applicant is Ceramed Corp.. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K960368. 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 OSTEOGRAFT/N-700 HYDROXYLAPTITE?

OSTEOGRAFT/N-700 HYDROXYLAPTITE is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Ceramed Corp.. The 510(k) number is K960368.

When did OSTEOGRAFT/N-700 HYDROXYLAPTITE receive FDA 510(k) clearance?

OSTEOGRAFT/N-700 HYDROXYLAPTITE received FDA 510(k) clearance on 1996-04-18, under 510(k) number K960368.

Who is the listed applicant for OSTEOGRAFT/N-700 HYDROXYLAPTITE?

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

What is the FDA product code for OSTEOGRAFT/N-700 HYDROXYLAPTITE?

The FDA product code for OSTEOGRAFT/N-700 HYDROXYLAPTITE is LYC.

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Other records listing Ceramed Corp. 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.

K962838PERMARIDGE SYRINGEK962786OSTEOGRAF STAINLESS STEEL SYRINGK960348OSTEOGRAF/N-300 HYDROXYLAPATITEK960353OSTEOGRAF/LD-300 HYDROXYLAPATITEK960361PERMAMESH-D HYDROXYLAPATITE MATRIXK960362PERMAMESH HYDROXYLAPATITE MATRIX

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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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