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)

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER

K-Number: K041324 · 2004-07-19

ApplicantLifecore Biomedical, Inc.
Decision Date2004-07-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 2004-07-19 under 510(k) number K041324. 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 CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER?

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER is a medical device that received FDA 510(k) clearance on 2004-07-19. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K041324.

When did CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER receive FDA 510(k) clearance?

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER received FDA 510(k) clearance on 2004-07-19, under 510(k) number K041324.

Who is the listed applicant for CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER?

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

What is the FDA product code for CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER?

The FDA product code for CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER 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 Lifecore Biomedical, Inc. 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.

K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSK072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMK072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSK072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSK062876PRIMACONNEX CERAMIC ABUTMENTSK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

View all 34 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.

↑