meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2010-11-17

Clearances · page 82 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102807 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2010-11-17
K100888 MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM Lanx, Inc. KWP Class II 2010-11-15
K102204 CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM Choicespine, LP NKB Class II 2010-11-15
K102326 PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR Parcus Medical, LLC HWC Class II 2010-11-15
K102162 PARCUS PEEK CF PUSH-IN SUTURE ANCHOR Parcus Medical, LLC HWC Class II 2010-11-10
K103012 EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS Exactech, Inc. LZO Class II 2010-11-10
K103007 AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM Tornier, Inc. KWS Class II 2010-11-09
K102215 KIRSCHNER WIRES, STEINMAN PINS Evergreen Orthopedic Research Lab HTY Class II 2010-11-09
K101400 LOCKING COMPRESSION PLATE Changzhou Orthmed Medical Instrument Co., Ltd. HRS Class II 2010-11-09
K101183 MODIFICATION TO: OASYS SYSTEM Stryker Spine KWP Class II 2010-11-09
K092541 INTERFACE Biostructures MQV Class II 2010-11-09
K101808 SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER Medshape Solutions HWC Class II 2010-11-08
K102487 NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 Exactech, Inc. LZO Class II 2010-11-08
K100407 LIFE SPINE INTERSPINOUS FIXATION SYSTEM Life Spine MNI Class II 2010-11-05
K102975 NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE Exactech, Inc. LPH Class II 2010-11-05
K102820 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Alphatec Spine, Inc. KWQ Class II 2010-11-05
K102067 ENDOSKELETON TO Titan Spine, LLC MAX Class II 2010-11-05
K101112 RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems KWP Class II 2010-11-04
K102951 EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) Exactech, Inc. PHX Class II 2010-11-04
K102072 MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) Memometal Technologies HTY Class II 2010-11-03
K102423 DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. LPH Class II 2010-10-29
K100926 ARROWHEAD FIXATION DEVICE Arrow Products, Inc. HTY Class II 2010-10-29
K101437 SPEEDFIX SUTURE SYSTEM Arthrocare Corp. MBI Class II 2010-10-29
K102545 FM-02 BONE GRAFT SUBSTITUTE Orthovita, Inc. MQV Class II 2010-10-27
K101525 PIONEER SPINOUS PROCESS FUSION PLATE Pioneer Surgical Technology KWP Class II 2010-10-22
K101759 QUANTUM RING FIXATION SYSTEM MODEL ISF Quantum Medical Concepts, LLC KTT Class II 2010-10-22
K100944 CLAVICLE LOCKING PLATE SYSTEM Newclip Technics HRS Class II 2010-10-22
K093293 VANGUARD 360 REVISION KNEE SYSTEM Biomet, Inc. JWH Class II 2010-10-22
K101679 ARTHREX PUSHLOCK ANCHORS Arthrex, Inc. MAI Class II 2010-10-22
K100976 T2 XVBR 1.5 SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MQP Class II 2010-10-21
K102262 ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL Arthrocare Corp. MBI Class II 2010-10-21
K102701 VIPER SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2010-10-20
K101936 CONTOURS VSP III VOLAR PLATING SYSTEM Orthofix, Inc. HRS Class II 2010-10-20
K102443 INTRAFIX TIBIAL SHEATH Depuy Mitek, A Johnson & Johnson Company MBI Class II 2010-10-20
K102903 PIONEER CANNULATED SCREW SYSTEM Pioneer Surgical Technology, Inc. HWC Class II 2010-10-20
K093803 BIO-MODULAR REVERSE SHOLDER Biomet Manufacturing Corp PHX Class II 2010-10-19
K101933 MODIFICATION TO:EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2010-10-18
K093471 KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP KARL STORZ Endoscopy-America, Inc. HRX Class II 2010-10-18
K093833 KAPSS SPINAL SYSTEM Robert Reid, Inc. MNI Class II 2010-10-15
K102331 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM Ldr Spine USA MNI Class II 2010-10-15
K101848 SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM Spinal Elements, Inc. KWQ Class II 2010-10-14
K101864 KYPHON XPANDER II INFLATABLE BONE TAMP Medtronic HRX Class II 2010-10-14
K093093 SMALL PLATEAU SPACER SYSTEM Life Spine ODP Class II 2010-10-13
K101700 IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC HWC Class II 2010-10-12
K101670 UNITED U2 BIPOLAR IMPLANT United Orthopedic Corp. KWY Class II 2010-10-08
K102248 EXCELLA II SPINAL SYSTEM MODEL EC2-00 Innovasis, Inc. NKB Class II 2010-10-07
K101939 OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM Merete Medical GmbH HSB Class II 2010-10-07
K102277 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE Vertebral Technologies, Inc. MAX Class II 2010-10-06
K093438 PARADIGM INTERSPINOUS FUSION PLATE Paradigm Spine, LLC KWP Class II 2010-10-06
K100933 CONSENSUS CS2 PLUS ACETABULAR INSERT Consensus Orthopedics, Inc. LPH Class II 2010-10-06
K100123 ACUMED WRIST ARTHRODESIS PLATE SYSTEM Acumed, LLC HRS Class II 2010-10-06
K102069 JOURNEY UNICONDYLAR TIBIAL BASEPLATES Smith & Nephew, Inc. HSX Class II 2010-10-05
K101084 CASPIAN SPINAL SYSTEM K2m, Inc. KWP Class II 2010-10-04
K092723 AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM Skeletal Dynamics, LLC HRX Class II 2010-10-04
K101622 ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS Zimmer, Inc. HSB Class II 2010-10-01
K100042 DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM Difusion Technologies MAX Class II 2010-10-01
K102090 SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM Spine Smith Partners L.P. OVD Class II 2010-09-30
K101772 TSRH(R) SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2010-09-30
K102156 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS Orthohelix Surgical Designs, Inc. HRS Class II 2010-09-30
K100391 DEPUY UNIVERSAL GRIPTION TF CONES DePuy Orthopaedics, Inc. JWH Class II 2010-09-29
K102265 LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM Ldr Spine USA KWQ Class II 2010-09-29
K092977 EBERLE SHAVER SYSTEM ACCESSORIES Efs Eberle Feinwerktechnische Systeme HRX Class II 2010-09-29
K091956 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 Encore Medical L.P. OIY Class II 2010-09-28
K100112 SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) Sonoma Orthopedic Products, Inc. HSB Class II 2010-09-28
K101994 APEX KNEE MODULAR TIBIA SYSTEM Omnlife Science JWH Class II 2010-09-28
K101812 CONSTRUX MINI PEEK SPACER SYSTEM Orthofix, Inc. ODP Class II 2010-09-27
K101962 MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2010-09-27
K093047 SMITH & NEPHEW CIRCULAR FIXATION SYSTEM Smith & Nephew, Inc. KTT Class II 2010-09-27
K091445 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2010-09-27
K102437 GMK REVISION KNEE SYSTEM Medacta International S.A. JWH Class II 2010-09-24
K101301 STALIF MIDLINE Centinel Spine MAX Class II 2010-09-24
K100037 ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD Advanced Vertebral Solutions, LLC MAX Class II 2010-09-23
K101761 EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 Exactech, Inc. LPH Class II 2010-09-21
K100479 PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE Arthrocare Corp. NDN Class II 2010-09-21
K100845 PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES Zimmer Spine, Inc. NKB Class II 2010-09-21
K101170 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM Acute Innovations, LLC KTT Class II 2010-09-17
K094050 ITOTAL CR KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2010-09-16
K101536 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM Synthes (Usa), LLC HRS Class II 2010-09-15
K101375 TRIMED X-FIX TriMed, Inc. NDK Class II 2010-09-15
K101976 INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET Omni Life Science, Inc. LPH Class II 2010-09-14
K092794 TRANSCORP ACIF SYSTEM Transcorp, Inc. ODP Class II 2010-09-13
K101696 MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM Zimmer, Inc. HWC Class II 2010-09-10
K100736 KIRSCHNER AND GUIDE WIRES Smt Schilling Metalltechnik GmbH HTY Class II 2010-09-10
K101288 STAXX XD SYSTEM Spine Wave, Inc. MQP Class II 2010-09-10
K101734 VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES Visionscope Technologies, LLC HRX Class II 2010-09-08
K101086 TAPERLOC COMPLETE Biomet, Inc. KWA Class III 2010-09-03
K102107 OSSTAPLE CHILL Biomedical Ent., Inc. JDR Class II 2010-09-03
K100243 QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC KWQ Class II 2010-09-02
K101310 VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC OVD Class II 2010-09-02
K100795 JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING Smith & Nephew, Inc. KTT Class II 2010-09-02
K093430 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. Exactech, Inc. KWS Class II 2010-09-02
K102020 VEGA SPAN SPINOUS PROCESS PLATE SYSTEM Spinefrontier, Inc. KWP Class II 2010-09-01
K101860 NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC MQV Class II 2010-09-01
K101070 EXPEDIUM SPINE SYSTEM Medos International SARL NKB Class II 2010-08-31
K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM Ascension Orthopedics, Inc. KWS Class II 2010-08-30
K100886 INBONE II TOTAL ANKLE REPLACEMENT Wrightmedicaltechnologyinc HSN Class II 2010-08-26
K101100 CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 Conmed Linvatec MAI Class II 2010-08-26
K101499 JOURNEY CR KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2010-08-26
K100210 TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T Trans1 Incorporated MAX Class II 2010-08-26
K093753 MDPO FRAME SYSTEM Mdpo, LLC KTT Class II 2010-08-26

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