Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSTEOGRAF/N-300 HYDROXYLAPATITE

K-Number: K960348 · 1996-04-22

ApplicantCeramed Corp.
Decision Date1996-04-22
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/N-300 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 1996-04-22 under 510(k) number K960348. 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-300 HYDROXYLAPATITE?

OSTEOGRAF/N-300 HYDROXYLAPATITE is a medical device that received FDA 510(k) clearance on 1996-04-22. The listed applicant is Ceramed Corp.. The 510(k) number is K960348.

When did OSTEOGRAF/N-300 HYDROXYLAPATITE receive FDA 510(k) clearance?

OSTEOGRAF/N-300 HYDROXYLAPATITE received FDA 510(k) clearance on 1996-04-22, under 510(k) number K960348.

Who is the listed applicant for OSTEOGRAF/N-300 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/N-300 HYDROXYLAPATITE?

The FDA product code for OSTEOGRAF/N-300 HYDROXYLAPATITE is LYC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYRINGK960353OSTEOGRAF/LD-300 HYDROXYLAPATITEK960368OSTEOGRAFT/N-700 HYDROXYLAPTITEK960361PERMAMESH-D HYDROXYLAPATITE MATRIXK960362PERMAMESH HYDROXYLAPATITE MATRIX

View all 16 devices →

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.

↑