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)

OSTEOVATION CMF BONE VOID FILLER

K-Number: K051784 · 2005-07-20

ApplicantSkeletal Kinetics, LLC
Decision Date2005-07-20
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOVATION CMF BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Kinetics, LLC. It received FDA 510(k) clearance on 2005-07-20 under 510(k) number K051784. 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 OSTEOVATION CMF BONE VOID FILLER?

OSTEOVATION CMF BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K051784.

When did OSTEOVATION CMF BONE VOID FILLER receive FDA 510(k) clearance?

OSTEOVATION CMF BONE VOID FILLER received FDA 510(k) clearance on 2005-07-20, under 510(k) number K051784.

Who is the listed applicant for OSTEOVATION CMF BONE VOID FILLER?

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

What is the FDA product code for OSTEOVATION CMF BONE VOID FILLER?

The FDA product code for OSTEOVATION CMF BONE VOID FILLER 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 Skeletal Kinetics, LLC 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.

K162864OsteoVation ImpactK120354BETA-TCP GRANULESK112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLERK111538SKAFFOLD CISK100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONK051123CALLOS IMPACT AND INJECT BONE VOID FILLER

View all 9 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.

↑