FDA 510(k)

FIBERGRAFT BG Putty Bone Graft Substitute

K-Number: K170306 · 2017-05-24

Decision Date2017-05-24

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FIBERGRAFT BG Putty Bone Graft Substitute is a medical device manufactured by Prosidyan, Inc.. It received FDA 510(k) clearance on 2017-05-24 under approval number K170306. 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 FIBERGRAFT BG Putty Bone Graft Substitute?

FIBERGRAFT BG Putty Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Prosidyan, Inc.. The 510(k) number is K170306.

When was FIBERGRAFT BG Putty Bone Graft Substitute approved by the FDA?

FIBERGRAFT BG Putty Bone Graft Substitute received FDA 510(k) clearance on 2017-05-24, under approval number K170306.

What company makes FIBERGRAFT BG Putty Bone Graft Substitute?

FIBERGRAFT BG Putty Bone Graft Substitute is manufactured by Prosidyan, Inc..

What is the FDA product code for FIBERGRAFT BG Putty Bone Graft Substitute?

The FDA product code for FIBERGRAFT BG Putty 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 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

Other Devices by Prosidyan, Inc.

K171284FIBERGRAFT BG Matrix Bone Graft Substitute K182670FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute K180080FIBERGRAFT BG Matrix Bone Graft Substitute K213803FIBERGRAFT Aeridyan Matrix Bone Graft Substitute K241426GPS Advanced; 5 cc GPS Advanced Cannula K253147FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute

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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.