Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRODENSE Bone Graft Substitute

K-Number: K182823 · 2018-11-02

ApplicantWrightmedicaltechnologyinc
Decision Date2018-11-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRODENSE Bone Graft Substitute is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2018-11-02 under approval number K182823. 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 PRODENSE Bone Graft Substitute?

PRODENSE Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K182823.

When was PRODENSE Bone Graft Substitute approved by the FDA?

PRODENSE Bone Graft Substitute received FDA 510(k) clearance on 2018-11-02, under approval number K182823.

What company makes PRODENSE Bone Graft Substitute?

PRODENSE Bone Graft Substitute is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for PRODENSE Bone Graft Substitute?

The FDA product code for PRODENSE Bone Graft Substitute is MQV.

Related Clinical Trials

NCT01234415 Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction COMPLETED NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT05706909 The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head ACTIVE_NOT_RECRUITING

Other Devices by Wrightmedicaltechnologyinc

K152062BIOFOAM Bone Wedge K153008INVISION Total Ankle Revision System K153635SALVATION(R) External Fixation System K171852DARCO Locking Bone Plate System K171067INVISION Total Ankle Revision System K170642GRAVITY™ Soft Tissue Repair System

View all 37 devices →

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.

↑