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FDA 510(k)

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)

K-Number: K240404 · 2024-03-05

ApplicantNovabone Products, LLC
Decision Date2024-03-05
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K240404. 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 NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)?

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Novabone Products, LLC. The 510(k) number is K240404.

When did NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) receive FDA 510(k) clearance?

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) received FDA 510(k) clearance on 2024-03-05, under 510(k) number K240404.

Who is the listed applicant for NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)?

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

What is the FDA product code for NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)?

The FDA product code for NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) 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.

NCT07225751A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.RECRUITINGNCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITINGNCT07492576Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site ManagementRECRUITINGNCT07512336A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis PatientsNOT_YET_RECRUITINGNCT07701473Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case SeriesNOT_YET_RECRUITING

Other records listing Novabone Products, 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.

K242299NovaBone Putty - Synthetic Bioactive Bone GraftK220498NovoGen Wound MatrixK163310NovaBone IRM

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.

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.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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