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FDA 510(k)

OSTEOGRAF/D-100 HYDROXYLAPATITE

K-Number: K942946 · 1994-10-05

ApplicantCeramed Corp.
Decision Date1994-10-05
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/D-100 HYDROXYLAPATITE is the device name listed in this FDA 510(k) record. The listed applicant is Ceramed Corp.. It received FDA 510(k) clearance on 1994-10-05 under 510(k) number K942946. 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 OSTEOGRAF/D-100 HYDROXYLAPATITE?

OSTEOGRAF/D-100 HYDROXYLAPATITE is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Ceramed Corp.. The 510(k) number is K942946.

When did OSTEOGRAF/D-100 HYDROXYLAPATITE receive FDA 510(k) clearance?

OSTEOGRAF/D-100 HYDROXYLAPATITE received FDA 510(k) clearance on 1994-10-05, under 510(k) number K942946.

Who is the listed applicant for OSTEOGRAF/D-100 HYDROXYLAPATITE?

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 OSTEOGRAF/D-100 HYDROXYLAPATITE?

The FDA product code for OSTEOGRAF/D-100 HYDROXYLAPATITE 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 HYDROXYLAPATITEK960368OSTEOGRAFT/N-700 HYDROXYLAPTITEK960353OSTEOGRAF/LD-300 HYDROXYLAPATITEK960361PERMAMESH-D 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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