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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 a medical device manufactured by Novabone Products, LLC. It received FDA 510(k) clearance on 2024-03-05 under approval 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. It is manufactured by Novabone Products, LLC. The 510(k) number is K240404.

When was NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) approved by the FDA?

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

What company makes NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)?

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) is manufactured by Novabone Products, LLC.

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

NCT07225751 A 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. RECRUITING NCT07512336 A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis Patients NOT_YET_RECRUITING NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

Other Devices by Novabone Products, LLC

K163310NovaBone IRM K220498NovoGen Wound Matrix K242299NovaBone Putty - Synthetic Bioactive Bone Graft

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

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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