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FDA 510(k)

OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH

K-Number: K921469 · 1992-06-25

ApplicantCeramed Corp.
Decision Date1992-06-25
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH is the device name listed in this FDA 510(k) record. The listed applicant is Ceramed Corp.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K921469. 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/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH?

OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Ceramed Corp.. The 510(k) number is K921469.

When did OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH receive FDA 510(k) clearance?

OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH received FDA 510(k) clearance on 1992-06-25, under 510(k) number K921469.

Who is the listed applicant for OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH?

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/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH?

The FDA product code for OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH 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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