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FDA 510(k)

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute

K-Number: K213803 · 2022-08-23

ApplicantProsidyan, Inc.
Decision Date2022-08-23
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute is a medical device manufactured by Prosidyan, Inc.. It received FDA 510(k) clearance on 2022-08-23 under approval number K213803. 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 Aeridyan Matrix Bone Graft Substitute?

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Prosidyan, Inc.. The 510(k) number is K213803.

When was FIBERGRAFT Aeridyan Matrix Bone Graft Substitute approved by the FDA?

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute received FDA 510(k) clearance on 2022-08-23, under approval number K213803.

What company makes FIBERGRAFT Aeridyan Matrix Bone Graft Substitute?

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute is manufactured by Prosidyan, Inc..

What is the FDA product code for FIBERGRAFT Aeridyan Matrix Bone Graft Substitute?

The FDA product code for FIBERGRAFT Aeridyan Matrix Bone Graft Substitute is MQV.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING 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

Other Devices by Prosidyan, Inc.

K171284FIBERGRAFT BG Matrix Bone Graft Substitute K170306FIBERGRAFT BG Putty Bone Graft Substitute K182670FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute K180080FIBERGRAFT BG 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.

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