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FDA 510(k)

BONESOURCE HYDROXYAPATITE CEMENT (HAC)

K-Number: K964537 · 1997-01-24

ApplicantOsteogenics, Inc.
Decision Date1997-01-24
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BONESOURCE HYDROXYAPATITE CEMENT (HAC) is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964537. 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 BONESOURCE HYDROXYAPATITE CEMENT (HAC)?

BONESOURCE HYDROXYAPATITE CEMENT (HAC) is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Osteogenics, Inc.. The 510(k) number is K964537.

When did BONESOURCE HYDROXYAPATITE CEMENT (HAC) receive FDA 510(k) clearance?

BONESOURCE HYDROXYAPATITE CEMENT (HAC) received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964537.

Who is the listed applicant for BONESOURCE HYDROXYAPATITE CEMENT (HAC)?

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

What is the FDA product code for BONESOURCE HYDROXYAPATITE CEMENT (HAC)?

The FDA product code for BONESOURCE HYDROXYAPATITE CEMENT (HAC) 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 Osteogenics, 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.

K061934XTACK983753STAR TEMPORARY WOUND COVERK953339BONESOURCE HYDROXYAPATITE CEMENT (HAC)

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.

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