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)

MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT

K-Number: K131673 · 2013-10-03

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2013-10-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K131673. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT?

MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K131673.

When did MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT receive FDA 510(k) clearance?

MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT received FDA 510(k) clearance on 2013-10-03, under 510(k) number K131673.

Who is the listed applicant for MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT?

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

What is the FDA product code for MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT?

The FDA product code for MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT is MQV.

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 Medtronic Sofamor Danek USA, 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.

K253011Catalyft PL Expandable Interbody SystemK261020Symmetrix™ L Spinal SystemK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemK260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemK254165Infinity™ OCT SystemK253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

View all 139 devices →

Related Devices (Code: MQV)

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.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, 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.

↑