FDA Product Code
FDA Product Code MQV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3045
510(k) Clearances — 493 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193040 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2019-11-30 | Special | PDF ↗ |
| K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019-11-03 | Traditional | PDF ↗ |
| K191513 | Altapore Shape | Baxter Healthcare Corporation | 2019-10-19 | Traditional | PDF ↗ |
| K191074 | Sorrento Bone Graft Substitute | Xenco Medical, LLC | 2019-09-27 | Traditional | PDF ↗ |
| K190371 | Morpheus-C | Biogennix, LLC | 2019-08-09 | Traditional | PDF ↗ |
| K191274 | BonAlive Granules | Bonalive Biomaterials, Ltd. | 2019-08-07 | Traditional | PDF ↗ |
| K191764 | Inion BioRestore | Inion OY | 2019-07-31 | Special | PDF ↗ |
| K190754 | Orthoss(R) | Geistlich Pharma AG | 2019-06-23 | Traditional | PDF ↗ |
| K190814 | AccuFill Bone Substitute Material | Zimmer Knee Creations | 2019-06-10 | Traditional | PDF ↗ |
| K190482 | IGNITE Bone Void Filler | Wrightmedicaltechnologyinc | 2019-05-28 | Traditional | PDF ↗ |
| K190110 | NanoBone SBX PUTTY, NanoBone QD | Artoss GmbH | 2019-04-23 | Traditional | PDF ↗ |
| K182074 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2019-03-21 | Traditional | PDF ↗ |
| K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | 2019-03-14 | Special | PDF ↗ |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018-12-20 | Traditional | PDF ↗ |
| K181958 | MagnetOs Putty | Kuros Biosciences B.V | 2018-12-06 | Traditional | PDF ↗ |
| K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018-11-02 | Special | PDF ↗ |
| K180758 | Osteocera Resorbable Bone Substitute | Wiltrom Corporation Limited | 2018-10-24 | Traditional | PDF ↗ |
| K181721 | Ceracell Ortho Foam | Curasan AG | 2018-09-17 | Traditional | PDF ↗ |
| K173933 | Sorrento Bioglass Bone Graft Substitute | Xenco Medical, LLC | 2018-09-13 | Traditional | PDF ↗ |
| K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018-09-12 | Traditional | PDF ↗ |
| K173424 | BioSphere Flex | Synergy Biomedical | 2018-09-12 | Traditional | PDF ↗ |
| K182107 | CarriGen PF | Etex Corporation | 2018-08-31 | Special | PDF ↗ |
| K181225 | ALTAPORE | Baxter Healthcare Corporation | 2018-08-31 | Traditional | PDF ↗ |
| K181306 | Actifuse Flow | Baxter Healthcare Corporation | 2018-08-17 | Special | PDF ↗ |
| K180853 | EP Granules BVF | Elute, Inc. | 2018-08-06 | Traditional | PDF ↗ |
| K181585 | JGH1 Core Deccompression Procedure Kit | AgNovos Healthcare USA, LLC | 2018-07-20 | Traditional | PDF ↗ |
| K181342 | JGH1 Bone Graft Substitute | AgNovos Healthcare USA, LLC | 2018-07-19 | Traditional | PDF ↗ |
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation Dba Dsm Biomedical | 2018-05-09 | Traditional | PDF ↗ |
| K180121 | Rafugen DBM | Cellumed Co., Ltd. | 2018-04-11 | Traditional | PDF ↗ |
| K173525 | NovoGro | Osteonovus, Inc. | 2018-04-06 | Traditional | PDF ↗ |
| K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018-04-06 | Traditional | PDF ↗ |
| K173362 | DSM Biomedical Calcium Phosphate Cement | Kensey Nash Corporation Dba Dsm Biomedical | 2018-04-03 | Traditional | PDF ↗ |
| K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | 2018-02-22 | Traditional | PDF ↗ |
| K172237 | Bicera Resorbable Bone Substitute | Wiltrom Corporation Limited | 2018-02-02 | Traditional | PDF ↗ |
| K171629 | ABCcolla Bone Graft | Acro Biomedical Co., Ltd. | 2018-02-01 | Traditional | PDF ↗ |
| K173301 | BioSphere MIS Putty (BioSphere MIS) | Synergy Biomedical, LLC | 2018-01-19 | Special | PDF ↗ |
| K170165 | Osteo-P Bone Graft Substitute | Molecular Matrix, Inc. | 2017-12-29 | Traditional | PDF ↗ |
| K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017-12-26 | Traditional | PDF ↗ |
| K172573 | ReBOSSIS85 | Orthorebirth Co., Ltd. | 2017-12-15 | Traditional | PDF ↗ |
| K172497 | NuVasive AttraX Scaffold | Nu Vasive, Incorporated | 2017-11-24 | Traditional | PDF ↗ |
| K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017-11-16 | Traditional | PDF ↗ |
| K170917 | Bi-Ostetic Bioactive Glass Foam | Berkeley Advanced Biomaterials | 2017-10-30 | Traditional | PDF ↗ |
| K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | 2017-09-25 | Traditional | PDF ↗ |
| K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017-08-24 | Traditional | PDF ↗ |
| K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2017-06-30 | Traditional | PDF ↗ |
| K170620 | ReBOSSIS85 | Orthorebirth Co., Ltd. | 2017-06-23 | Traditional | PDF ↗ |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2017-05-24 | Traditional | PDF ↗ |
| K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017-05-02 | Traditional | PDF ↗ |
| K162087 | NovoGro | Osteonovus, Inc. | 2017-04-18 | Traditional | PDF ↗ |
| K161859 | MagnetOs | Xpand Biotechnology BV | 2017-02-24 | Traditional | PDF ↗ |
| K161996 | 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE | Amend Surgical, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K162860 | MCS Bone Graft | Bioventus, LLC | 2017-02-13 | Traditional | PDF ↗ |
| K163310 | NovaBone IRM | Novabone Products, LLC | 2017-01-18 | Traditional | PDF ↗ |
| K160566 | Cerasorb Ortho Foam | Curasan AG | 2016-12-02 | Traditional | PDF ↗ |
| K160446 | MCP Bone Putty | Biostructures, LLC | 2016-11-07 | Traditional | PDF ↗ |
| K161351 | NanoBone SBX Putty | Artoss GmbH | 2016-10-26 | Traditional | PDF ↗ |
| K161447 | HydroSet XT | Orthovita, Inc. | 2016-10-06 | Traditional | PDF ↗ |
| K152077 | MaxiGen | Hans Biomed Corp. | 2016-04-21 | Traditional | PDF ↗ |
| K151271 | BellaFuse | Hans Biomed Corp. | 2016-03-11 | Traditional | PDF ↗ |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | Orthovita, Inc. | 2016-02-12 | Special | PDF ↗ |
| K152589 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | 2016-01-12 | Traditional | PDF ↗ |
| K151154 | FIBERGRAFT BG Morsels | Prosidyan, Inc. | 2015-11-10 | Traditional | PDF ↗ |
| K151584 | AttraX Putty | Progentix Orthobiology BV | 2015-10-08 | Traditional | PDF ↗ |
| K150064 | Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) | Orthogem, Ltd. | 2015-09-04 | Traditional | PDF ↗ |
| K152071 | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) | Novabone Products, LLC | 2015-08-26 | Special | PDF ↗ |
| K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | Tcm Associates, Ltd. | 2015-08-21 | Traditional | PDF ↗ |
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | Bacterin International, Inc. | 2015-08-18 | Traditional | PDF ↗ |
| K151172 | MASTERGRAFT Contain | Medtronic Sofamor Danek USA, Inc. | 2015-08-14 | Traditional | PDF ↗ |
| K141725 | BONGOLD BONE GRAFT MATERIAL | Beijing Allgens Medical Science & Technology Co, L | 2015-07-09 | Traditional | PDF ↗ |
| K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | Prosidyan, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K141429 | SORRENTO BONE GRAFT SUBSTITUTE | Haider Biologics, LLC | 2015-02-23 | Traditional | PDF ↗ |
| K132868 | CARRICELL | Etex Corporation | 2015-02-20 | Traditional | PDF ↗ |
| K140913 | NUROS BONE GRAFT SUBSTITUTE | Oriental Resources Development Limited | 2015-02-17 | Traditional | PDF ↗ |
| K141189 | NANOBONE / GRANULATE | Artoss GmbH | 2015-01-30 | Traditional | PDF ↗ |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | Biocomposites, Ltd. | 2015-01-23 | Traditional | PDF ↗ |
| K142104 | NANOFUSE DBM | Nanotherapeutics, Inc. | 2015-01-21 | Traditional | PDF ↗ |
| K142276 | MCS Bone Graft | Biostructures, LLC | 2015-01-16 | Traditional | PDF ↗ |
| K142828 | osteoSPAN Morpheus | Biogennix | 2015-01-15 | Traditional | PDF ↗ |
| K143549 | Vivorte Trabexus | Vivorte, Inc. | 2015-01-14 | Special | PDF ↗ |
| K142463 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K141207 | NOVABONE BIOACTIVE STRIP | Novabone Products, LLC | 2014-10-31 | Traditional | PDF ↗ |
| K142090 | REBOSSIS | Orthorebirth Co., Ltd. | 2014-10-29 | Traditional | PDF ↗ |
| K141600 | NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014-10-17 | Traditional | PDF ↗ |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Medtronic Sofamor Danek, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K133678 | CONFIRM BIOACTIVE | Globus Medical, Inc. | 2014-08-26 | Traditional | PDF ↗ |
| K140946 | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE | Novabone Products, LLC | 2014-08-22 | Traditional | PDF ↗ |
| K141956 | FIBERGRAFT BG MORSELS | Prosidyan, Inc. | 2014-08-13 | Special | PDF ↗ |
| K132211 | SKAFFOLD NMX BONE VOID FILLER | Skeletal Kinetics, LLC | 2014-08-04 | Traditional | PDF ↗ |
| K141746 | AS20 COMPOSITE GRAFT | Wrightmedicaltechnologyinc | 2014-08-04 | Traditional | PDF ↗ |
| K141841 | INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP | Integra Lifescience Corportation | 2014-08-01 | Special | PDF ↗ |
| K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | Synergy Biomedical, Inc. | 2014-07-16 | Traditional | PDF ↗ |
| K132470 | SOLUM IV BONE VOID FILLER | Spinesmith Partners, Llp | 2014-05-21 | Traditional | PDF ↗ |
| K132377 | OSTEOSPAN MORPHEUS | Biogennix, LLC | 2014-05-20 | Traditional | PDF ↗ |
| K140375 | MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Medtronic Sofamor Danek USA, Inc. | 2014-04-18 | Traditional | PDF ↗ |
| K130531 | ULTRAFUSE | Baxter Healthcare Corp | 2014-04-08 | Traditional | PDF ↗ |
| K132656 | PRODENSE BONE GRAFT SUBSTITUTE | Wrightmedicaltechnologyinc | 2014-03-24 | Traditional | PDF ↗ |
| K132805 | BG MORSELS | Prosidyan, Inc. | 2014-03-14 | Traditional | PDF ↗ |
| K132050 | NB3D BONE VOID FILLER | Pioneer Surgical Technology, Inc. | 2014-02-07 | Traditional | PDF ↗ |
| K132071 | BIOACTIVE BONE GRAFT PUTTY | Biostructures, LLC | 2014-01-10 | Traditional | PDF ↗ |
| K130977 | SIGNIFY BIOACTIVE | Globus Medical, Inc. | 2013-12-24 | Traditional | PDF ↗ |
Product code MQV · Class II · Orthopedic. Data: openFDA.