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FDA 510(k)

FIBERGRAFT BG Matrix Bone Graft Substitute

K-Number: K180080 · 2018-04-06

ApplicantProsidyan, Inc.
Decision Date2018-04-06
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIBERGRAFT BG 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 2018-04-06 under 510(k) number K180080. 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 Matrix Bone Graft Substitute?

FIBERGRAFT BG Matrix Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Prosidyan, Inc.. The 510(k) number is K180080.

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

FIBERGRAFT BG Matrix Bone Graft Substitute received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180080.

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

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

Related Clinical Trials

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Other records listing Prosidyan, Inc. as applicant

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.

K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteK251648GPS Advanced; GPS Advanced CannulaK241426GPS Advanced; 5 cc GPS Advanced CannulaK213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteK182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteK171284FIBERGRAFT BG Matrix Bone Graft Substitute

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Related Devices (Code: MQV)

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.

K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ 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 SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ 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.

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