FDA 510(k)

Synthetic Bone Putty

K-Number: K221644 · 2022-09-02

Decision Date2022-09-02

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Synthetic Bone Putty is a medical device manufactured by Ventris Medical. It received FDA 510(k) clearance on 2022-09-02 under approval number K221644. 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 Synthetic Bone Putty?

Synthetic Bone Putty is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Ventris Medical. The 510(k) number is K221644.

When was Synthetic Bone Putty approved by the FDA?

Synthetic Bone Putty received FDA 510(k) clearance on 2022-09-02, under approval number K221644.

What company makes Synthetic Bone Putty?

Synthetic Bone Putty is manufactured by Ventris Medical.

What is the FDA product code for Synthetic Bone Putty?

The FDA product code for Synthetic Bone Putty 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

Other Devices by Ventris Medical

K240765Porous Biologic Scaffold K240458Synthetic Bone Putty K250556Porous Biologic Scaffold

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

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