ClearanceBrief
Panels › Orthopedic › Product code MQV · Class 2

Filler, Bone Void, Calcium Compound

Regulation 888.3045

5510(k)s in 12 months (493 all time)
5recalls in 12 months (120 all time)
103recalls that name a 510(k)
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Top companies in MQV

Company510(k)sRecalls
Regeneration Technologies, Inc.527
Skeletal Kinetics, LLC624
Wrightmedicaltechnologyinc280
Novabone Products, LLC190
Medtronic Sofamor Danek161
Berkeley Advanced Biomaterials141
Etex Corp.140
Musculoskeletal Transplant Foundation95
Biocomposites, Ltd.111
Kuros Biosciences120
Decided510(k)Device and applicantCode
Feb 16, 2017K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
Amend Surgical, Inc.
MQV
Feb 13, 2017K162860MCS Bone Graft
Bioventus, LLC
MQV
Jan 18, 2017K163310NovaBone IRM
Novabone Products, LLC
MQV
Dec 2, 2016K160566Cerasorb Ortho Foam
Curasan AG, DE
MQV
Nov 7, 2016K160446MCP Bone Putty
Biostructures, LLC
MQV
Oct 26, 2016K161351NanoBone SBX Putty
Artoss GmbH, DE
MQV
Oct 6, 2016K161447HydroSet XT
Orthovita, Inc.
MQV
Apr 21, 2016K152077MaxiGen
Hans Biomed Corp., KR
MQV
Mar 11, 2016K151271BellaFuse
Hans Biomed Corp., KR
MQV
Feb 12, 2016K153608Vitoss BiModal Bone Graft Substitute Foam Strip
Orthovita, Inc.
MQV
Jan 12, 2016K152589Bio2 CLM BG Bioactive Scaffold
Bio2 Technologies, Inc.
MQV
Nov 10, 2015K151154FIBERGRAFT BG Morsels
Prosidyan, Inc.
MQV
Oct 8, 2015K151584AttraX Putty
Progentix Orthobiology BV, NL
MQV
Sep 4, 2015K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
Orthogem, Ltd., GB
MQV
Aug 26, 2015K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
Novabone Products, LLC
MQV
Aug 21, 2015K143692GranOSTM - beta tricalcium phosphate synthetic bone granules
Tcm Associates, Ltd., GB
MQV
Aug 18, 2015K150621OsteoSelect PLUS Demineralized Bone Matrix Putty
Bacterin International, Inc.
MQV
Aug 14, 2015K151172MASTERGRAFT Contain
Medtronic Sofamor Danek USA, Inc.
MQV
Jul 9, 2015K141725BONGOLD BONE GRAFT MATERIAL
Beijing Allgens Medical Science & Technology Co, L
MQV
Mar 25, 2015K143533FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
Prosidyan, Inc.
MQV
Feb 23, 2015K141429SORRENTO BONE GRAFT SUBSTITUTE
Haider Biologics, LLC
MQV
Feb 20, 2015K132868CARRICELL
Etex Corporation
MQV
Feb 17, 2015K140913NUROS BONE GRAFT SUBSTITUTE
Oriental Resources Development Limited, TW
MQV
Jan 30, 2015K141189NANOBONE / GRANULATE
Artoss GmbH, DE
MQV
Jan 23, 2015K141830STIMULAN KIT, STIMULAN RAPID CURE
Biocomposites, Ltd., GB
MQV
Jan 21, 2015K142104NANOFUSE DBM
Nanotherapeutics, Inc.
MQV
Jan 16, 2015K142276MCS Bone Graft
Biostructures, LLC
MQV
Jan 15, 2015K142828osteoSPAN Morpheus
Biogennix
MQV
Jan 14, 2015K143549Vivorte Trabexus
Vivorte, Inc.
MQV
Dec 18, 2014K142463Bio2 CLM BG Bioactive Scaffold
Bio2 Technologies, Inc.
MQV
Oct 31, 2014K141207NOVABONE BIOACTIVE STRIP
Novabone Products, LLC
MQV
Oct 29, 2014K142090REBOSSIS
Orthorebirth Co., Ltd.
MQV
Oct 17, 2014K141600NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
Pioneer Surgical Technology, Inc. (Rti Surgical, I
MQV
Sep 5, 2014K141824MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP
Medtronic Sofamor Danek, Inc.
MQV
Aug 26, 2014K133678CONFIRM BIOACTIVE
Globus Medical, Inc.
MQV
Aug 22, 2014K140946NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
Novabone Products, LLC
MQV
Aug 13, 2014K141956FIBERGRAFT BG MORSELS
Prosidyan, Inc.
MQV
Aug 4, 2014K141746AS20 COMPOSITE GRAFT
Wrightmedicaltechnologyinc
MQV
Aug 4, 2014K132211SKAFFOLD NMX BONE VOID FILLER
Skeletal Kinetics, LLC
MQV
Aug 1, 2014K141841INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
Integra Lifescience Corportation
MQV
Jul 16, 2014K140844BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
Synergy Biomedical, Inc.
MQV
May 21, 2014K132470SOLUM IV BONE VOID FILLER
Spinesmith Partners, Llp
MQV
May 20, 2014K132377OSTEOSPAN MORPHEUS
Biogennix, LLC
MQV
Apr 18, 2014K140375MASTERGRAFT PUTTY, MASTERGRAFT STRIP
Medtronic Sofamor Danek USA, Inc.
MQV
Apr 8, 2014K130531ULTRAFUSE
Baxter Healthcare Corp
MQV
Mar 24, 2014K132656PRODENSE BONE GRAFT SUBSTITUTE
Wrightmedicaltechnologyinc
MQV
Mar 14, 2014K132805BG MORSELS
Prosidyan, Inc.
MQV
Feb 7, 2014K132050NB3D BONE VOID FILLER
Pioneer Surgical Technology, Inc.
MQV
Jan 10, 2014K132071BIOACTIVE BONE GRAFT PUTTY
Biostructures, LLC
MQV
Dec 24, 2013K130977SIGNIFY BIOACTIVE
Globus Medical, Inc.
MQV

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