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)

BSM- BONE SUBSTITUTE MATERIAL

K-Number: K983009 · 1998-11-25

ApplicantEtex Corp.
Decision Date1998-11-25
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BSM- BONE SUBSTITUTE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983009. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSM- BONE SUBSTITUTE MATERIAL?

BSM- BONE SUBSTITUTE MATERIAL is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Etex Corp.. The 510(k) number is K983009.

When did BSM- BONE SUBSTITUTE MATERIAL receive FDA 510(k) clearance?

BSM- BONE SUBSTITUTE MATERIAL received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983009.

Who is the listed applicant for BSM- BONE SUBSTITUTE MATERIAL?

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

What is the FDA product code for BSM- BONE SUBSTITUTE MATERIAL?

The FDA product code for BSM- BONE SUBSTITUTE MATERIAL is GXP.

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 Etex 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.

K100883CARRIGENK101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENK093447CARRIGENK091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

View all 18 devices →

Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.

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.

↑