FDA 510(k)

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute

K-Number: K213803 · 2022-08-23

Decision Date2022-08-23

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FIBERGRAFT Aeridyan Matrix Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Prosidyan, Inc.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) 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. The listed applicant is Prosidyan, Inc.. The 510(k) number is K213803.

When did FIBERGRAFT Aeridyan Matrix Bone Graft Substitute receive FDA 510(k) clearance?

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

Who is the listed applicant for FIBERGRAFT Aeridyan Matrix Bone Graft Substitute?

The FDA 510(k) record lists Prosidyan, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07059065FIBERGRAFT Aeridyan Posterolateral Fusion StudyRECRUITING NCT01234415Bone Substitute in the Multi Traumatized Nasal Septum ReconstructionCOMPLETED NCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITING NCT05706909The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral HeadACTIVE_NOT_RECRUITING NCT07057817The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb SalvageRECRUITING NCT07569146Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.COMPLETED

Other records listing Prosidyan, Inc. as applicant

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 K251648GPS Advanced; GPS Advanced Cannula K241426GPS Advanced; 5 cc GPS Advanced Cannula K182670FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute K180080FIBERGRAFT BG Matrix Bone Graft Substitute K171284FIBERGRAFT BG Matrix Bone Graft Substitute

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Related Devices (Code: MQV)

K260364Device 300419 StripGeistlich Pharma AG K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker Spine K253524Adaptos®Fuse Bone GraftBiomendex OY K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.

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.