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FDA 510(k)

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft

K-Number: K200064 · 2020-08-14

ApplicantSurGenTec, LLC
Decision Date2020-08-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K200064. 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 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is SurGenTec, LLC. The 510(k) number is K200064.

When did OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft receive FDA 510(k) clearance?

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft received FDA 510(k) clearance on 2020-08-14, under 510(k) number K200064.

Who is the listed applicant for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?

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

What is the FDA product code for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?

The FDA product code for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is MQV.

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Other records listing SurGenTec, LLC 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.

K262121Ion-L Navigated InstrumentsK261209Ion-LK260329Ion-C Navigation InstrumentsK253604TiLink-L Navigation InstrumentsK251714Ion-CK251720OsteoFlo HydroFiber

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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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