meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2009-06-15

Clearances · page 88 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090289 CLAVICLE PLATING SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2009-06-15
K083449 E-MATRIX GRAFT BONE EXTENDER Pioneer Surgical Technology MQV Class II 2009-06-12
K090998 DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. JDI Class II 2009-06-12
K090648 VIPER 2 SYSTEM Depuy Spine, Inc. NKB Class II 2009-06-10
K091266 THEKEN CORAL SPINAL SYSTEM Theken Spine, LLC NKB Class II 2009-06-10
K090132 MAXMORESPINE SPINAL SYSTEM Hoogland Spine Products, GmbH HRX Class II 2009-06-09
K090926 SMITH & NEPHEW RAIL SYSTEM Smith & Nephew, Inc. KTT Class II 2009-06-08
K080108 CORTOSS BONE AUGMENTATION MATERIAL Orthovita, Inc. NDN Class II 2009-06-05
K091253 THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2m, Inc. KWQ Class II 2009-06-04
K083772 COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc. JWH Class II 2009-06-04
K090675 SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES Smith & Nephew, Inc. HRS Class II 2009-06-04
K090656 INTERTAN CHS LIMITED COLLAPSE SET SCREW Smith & Nephew, Inc. HWC Class II 2009-06-03
K090615 OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE Arthrocare Corp. MBI Class II 2009-06-03
K090060 NEXLINK OCT SYSTEM, MODEL 7000 SERIES Abbott Spine, Inc. KWP Class II 2009-06-02
K082166 MASTERGRAFT STRIP Medtronic Sofamor Danek MQV Class II 2009-06-02
K090415 EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM Eminent Spine KWQ Class II 2009-06-01
K090566 PATHWAY AVID Custom Spine, Inc. MAX Class II 2009-06-01
K091069 MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT Medacta International S.A. HWC Class II 2009-06-01
K083118 SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE Spinal USA ODP Class II 2009-05-27
K082419 REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 Intra-Lock International, Inc. MQV Class II 2009-05-27
K081122 FUSION MEDICAL CANNULATED SCREW SYSTEM John Riccio HWC Class II 2009-05-26
K090208 BIOPRO FEMORAL HEADS Biopro, Inc. JDI Class II 2009-05-22
K081917 DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS Depuy Spine, Inc. MAX Class II 2009-05-22
K090815 PERCUTANEOUS DISCECTOMY SYSTEM Laurimed, LLC HRX Class II 2009-05-21
K090549 SYNTHES SYNAPSE TRANSCONNECTOR Synthes Spine KWP Class II 2009-05-21
K071004 OSTEOCRETE BONE VOID FILLER Bone Solutions, Inc. MQV Class II 2009-05-21
K081755 FUSION MEDICAL STI John Riccio HWC Class II 2009-05-20
K090440 HINGE PEDIATRIC PLATING SYSTEM Pega Medical, Inc. HRS Class II 2009-05-20
K090530 SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 Ross Creek Medical, Inc. MBI Class II 2009-05-20
K090899 DEPUY SPINE LATERAL SYSTEM Depuy Spine, Inc. MAX Class II 2009-05-19
K090425 GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM Alphatec Spine, Inc. MAX Class II 2009-05-19
K090390 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2009-05-15
K083648 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL Efratgo, Ltd. HI Tech Bio-Surgical HSB Class II 2009-05-14
K090424 DVX SPINE SYSTEM Bk Meditech, Co., Ltd. MNH Class II 2009-05-14
K090354 LAMINOPLASTY PLATING SYSTEM Aesculap Implant System, Inc. NQW Class II 2009-05-12
K091071 NUVASIVE LATERAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2009-05-08
K090692 ORTHOLOC 2.0/2.4 PLATE SYSTEM Wrightmedicaltechnologyinc HRS Class II 2009-05-08
K090033 MODIFICATION TO: PSS SYSTEM Spinal USA MNI Class II 2009-05-06
K090994 LIGAFIX INTERFACE SCREW Science For Biomaterials HWC Class II 2009-05-06
K090024 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM Alexandria Research Technologies, LLC HSX Class II 2009-05-04
K090127 METATARSAL DECOMPRESSION IMPLANT, MODEL 100 Solana Surgical, LLC KWD Class II 2009-05-01
K090303 XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 Corespine Technologies, LLC HRX Class II 2009-04-30
K090228 ROC LUMBAR PLATING SYSTEM Alphatec Spine, Inc. MNH Class II 2009-04-29
K090222 PIONEER LUMBAR PLATE SYSTEM Pioneer Surgical Technology KWQ Class II 2009-04-28
K090176 NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM Nuvasive, Inc. MQP Class II 2009-04-27
K090816 STRYKER SPINE AVS PL PEEK SPACERS Stryker Corp. MAX Class II 2009-04-24
K090299 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS Aesculap Implant Systems LZO Class II 2009-04-24
K090839 MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS Syntec Scientific Corp. HRS Class II 2009-04-24
K090666 PEDIPLATES OrthoPediatrics Corp. HRS Class II 2009-04-24
K082934 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM Extremity Medical, LLC HWC Class II 2009-04-23
K090053 APTUS 2.0 RADIAL HEAD SYSTEM Medartis AG HRS Class II 2009-04-23
K090799 MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2009-04-22
K090782 NOVEL ALIF SPINAL SPACER SYSTEM Alphatec Spine, Inc. MAX Class II 2009-04-22
K090063 MERETE LOCKING BONE PLATE SYSTEM Merete Medical, Inc. KTT Class II 2009-04-22
K090166 AVS ANTERIOR LARGE PEEK SPACERS Stryker Corp. MAX Class II 2009-04-22
K082698 ALEUTIAN IBF SYSTEM K2m, Inc. MAX Class II 2009-04-21
K090764 NOVATION CFS PRESS-FIT AND CEMENTED STEMS Exactech, Inc. LWJ Class II 2009-04-21
K083815 LANX FUSION SYSTEM Lanx, Inc. MAX Class II 2009-04-20
K083637 CALIX SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. ODP Class II 2009-04-20
K090657 MODIFICATION TO: S4 SPINAL SYSTEM Aesculap Implant Systems NKB Class II 2009-04-20
K083096 LATARJET CORTICAL SCREW SET Tag Medical Products HWC Class II 2009-04-17
K090714 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2009-04-17
K083714 ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) Titan Spine, LLC MAX Class II 2009-04-15
K090278 ENSPIRE DEBRIDER SYSTEM Spine View, Inc. HRX Class II 2009-04-15
K090731 NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD Novabone Products, LLC MQV Class II 2009-04-15
K090460 BONOS INJECT Aap Biomaterials GmbH NDN Class II 2009-04-14
K090186 CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES Linvatec Corp. MAI Class II 2009-04-10
K082309 CAMBRIA Seaspine, Inc. ODP Class II 2009-04-09
K090064 EMINENT SPINE INTERBODY FUSION SYSTEM Eminent Spine MAX Class II 2009-04-09
K083284 PIEZOSURGERY MEDICAL Piezosurgery S.R.L. JDX Class II 2009-04-08
K083116 VERSAFIT CUP DOUBLE MOBILITY SYSTEM Medacta International S.A. MEH Class II 2009-04-07
K090316 MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM Lanx, Inc. KWQ Class II 2009-04-07
K083581 LANX SPINAL FIXATION SYSTEM Lanx, Inc. MNH Class II 2009-04-07
K090411 FREEDOM METAL BACKED TIBIAL COMPONENT Maxx Orthopedics, Inc. JWH Class II 2009-04-07
K082679 LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X Sintea Biotech, Inc. JEC Class II 2009-04-07
K083779 MAK OSS KNEE FEMORAL COMPONENTS Biomet Manufacturing Corp KRO Class II 2009-04-03
K083782 REGENEREX PATELLA COMPONENTS Biomet Manufacturing Corp MBH Class II 2009-04-03
K090669 RIGIDFIX BIOCRYL CROSS PIN KITS Depuy Mitek, A Johnson & Johnson Company MAI Class II 2009-04-03
K081770 BLACK WIDOW ANTERIOR BUTTRESS PLATE Omni Surgical, L.P. KWQ Class II 2009-04-02
K082793 INTERGRO DBM Biomet Spine MQV Class II 2009-04-02
K083393 XIA 3 SPINAL SYSTEM Stryker Spine NKB Class II 2009-04-01
K090047 SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM Synthes (Usa) HRS Class II 2009-04-01
K090376 SPINESMITH CYNCH SPINAL SYSTEM Spine Smith Partners L.P. MAX Class II 2009-04-01
K090492 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS DePuy Orthopaedics, Inc. HRS Class II 2009-03-31
K083863 THEKEN ATOLL OCT SPINAL SYSTEM Theken Spine, LLC MNI Class II 2009-03-27
K083161 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) Conmed Linvatec HRX Class II 2009-03-27
K081978 RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC MNI Class II 2009-03-26
K090478 AOS PROXIMAL HUMERAL NAIL Advanced Orthopaedic Solutions, Inc. HSB Class II 2009-03-26
K083389 COALITION SPACER Globus Medical, Inc. OVE Class II 2009-03-26
K083020 STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM Stryker Corp. KWQ Class II 2009-03-26
K090473 DISCOVERY ELBOW - X-SMALL Biomet Manufacturing Corp JDC Class II 2009-03-25
K083792 WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 Medshape Solutions HWC Class II 2009-03-25
K083562 STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM Stryker Corp. KWQ Class II 2009-03-25
K090310 EQUIVABONE Etex Corp. MQV Class II 2009-03-24
K083789 ACE FISCHER EXTERNAL FIXATION SYSTEM DePuy Orthopaedics, Inc. KTT Class II 2009-03-23
K090408 MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC NKB Class II 2009-03-20
K083830 OSCAR BONE RESECTOR Orthosonics, Ltd. JDX Class II 2009-03-20
K083341 NUVASIVE HELIX-T ACP SYSTEM Nuvasive, Inc. KWQ Class II 2009-03-20
K083425 FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE Adaptive Specialty, LLC ODP Class II 2009-03-20
K083843 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DePuy Orthopaedics, Inc. HRS Class II 2009-03-20

17,115 clearances in the Orthopedic panel. Data: openFDA.