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510(k) K193487

Device
Agilon Strip
Applicant
Biogennix, LLC
510(k) number
K193487
Product code
MQV  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-30
Date received
2019-12-17
Regulation
888.3045
Classification name
Filler, Bone Void, Calcium Compound
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Timothy Bumbalough
Address
1641 Mcgaw Ave. Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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 Spine2026-04-24
K253524Adaptos®Fuse Bone GraftBiomendex OY2026-02-17
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.2025-10-22
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.2025-10-13
K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)2025-09-30
K251556Device 300423 GranulesGeistlich Pharma AG2025-07-17
K251720OsteoFlo HydroFiberSurGenTec, LLC2025-07-02
K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc.2025-06-12
K243949OsteoFlo HydroFiberSurGenTec, LLC2025-05-28
K243474MagnetOs MISKuros Biosciences B.V2025-05-23
K250141Synthecure Synthetic Calcium SulfateAustin Medical Ventures, Inc.2025-05-16
K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.2025-04-07
K250556Porous Biologic ScaffoldVentris Medical2025-03-21
K250346BonVie+Elute, Inc.2025-02-26
K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.2025-02-21

Legacy Summary#

summary

FDA Review#

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