meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2009-03-19

Clearances · page 89 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K083825 EOI SPINAL SYSTEM Expanding Orthopedics, Inc. NKB Class II 2009-03-19
K083490 BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 Biopro, Inc. HTY Class II 2009-03-18
K090076 SALTO TALARIS TOTAL ANKLE PROSTHESIS Tornier HSN Class II 2009-03-17
K083651 REVELATION STEM, MODEL 427-21/42-080/180 Encore Medical L.P. KWA Class III 2009-03-13
K090380 MAGNUM M FIXATION DEVICE Arthrocare Corp. MBI Class II 2009-03-13
K083073 THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC MNI Class II 2009-03-13
K081813 UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM U.S. Implant Solutions, LLC HWC Class II 2009-03-12
K083726 PEDINAIL INTRAMEDULLARY NAILING SYSTEM OrthoPediatrics Corp. HSB Class II 2009-03-11
K090124 GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 Depuy Mitek, A Johnson & Johnson Company MAI Class II 2009-03-11
K090374 STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S DePuy Orthopaedics, Inc. LXT Class II 2009-03-11
K083762 BIOLOX DELTA CERAMIC FEMORAL HEADS Smith & Nephew, Inc. LZO Class II 2009-03-11
K083609 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE Kfx Medical MBI Class II 2009-03-06
K090075 PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 Parcus Medical, LLC MBI Class II 2009-03-06
K090230 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2009-03-06
K083694 SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES Synthes (Usa) HRS Class II 2009-03-06
K083619 PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 Parcus Medical, LLC HWC Class II 2009-03-06
K083642 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DePuy Orthopaedics, Inc. KWA Class III 2009-03-06
K083558 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C Medacta International S.A. LZO Class II 2009-03-06
K082924 DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER Wrightmedicaltechnologyinc KWA Class III 2009-03-06
K083573 SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES Synthes (Usa) HRS Class II 2009-03-04
K090252 MODIFICATION TO: LANX SPINAL FIXATION SYSTEM Lanx, Inc. KWP Class II 2009-03-04
K083311 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM Aesculap Implant Systems, Inc. ODP Class II 2009-03-04
K080611 MESA SPINAL SYSTEM K2m, Inc. MNH Class II 2009-03-04
K083612 APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM Cayenne Medical, Inc. HWC Class II 2009-03-04
K083607 APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM Cayenne Medical, Inc. HWC Class II 2009-03-04
K083566 R3 CONSTRAINED LINER, CONSTRAINED LINER Smith & Nephew, Inc. KWZ Class II 2009-03-03
K083636 REPROCESSED EXTERNAL FIXATION DEVICE Sterilmed, Inc. KTT Class II 2009-03-02
K083661 AVS TL PEEK SPACERS Stryker Corp. MAX Class II 2009-02-27
K081240 TIGER DISCECTOMY DEVICE Spinal Devices, LLC HRX Class II 2009-02-27
K083654 ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) Zimmer, Inc. HRS Class II 2009-02-26
K083663 PACP Pioneer Surgical Technology KWQ Class II 2009-02-25
K082498 GRAFTYS HBS Graftys MQV Class II 2009-02-25
K083178 SOLAS ANATOMIX SPINAL SYSTEM Biotechni America Spine Group, Inc. MNI Class II 2009-02-23
K073439 TRANSITION STABILIZATION SYSTEM Globus Medical, Inc. NQP Class II 2009-02-20
K090242 GAMMA-BSM, BETA-BSM Etex Corp. MQV Class II 2009-02-20
K081400 FANNING-PAPPAS MODULAR KNEE BEARING Endotec, Inc. JWH Class II 2009-02-20
K081479 ADVANCE A-CLASS TIBIAL INSERT Wrightmedicaltechnologyinc MBH Class II 2009-02-20
K090177 INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE Inion OY MQV Class II 2009-02-20
K083497 ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS Zimmer, Inc. HSB Class II 2009-02-19
K082468 APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) Omni Life Science, Inc. KWY Class II 2009-02-18
K082300 ANATOMIC LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc. HRS Class II 2009-02-18
K083475 LUCENT MAGNUM Spinal Elements, Inc. OVD Class II 2009-02-13
K083469 METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 Metasurg KWD Class II 2009-02-13
K083827 ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES Biomet Manufacturing Corp KRO Class II 2009-02-13
K083857 LDR SPINE ROI-C IMPLANT Ldr Spine USA MQP Class II 2009-02-12
K083268 TORNIER, INC., INSITE SUTURE ANCHORS Tornier, Inc. MAI Class II 2009-02-12
K090103 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL Biomet, Inc. MAY Class II 2009-02-11
K083107 MODIFICATION TO DEPUY NEUFLEX PIP FINGER DePuy Orthopaedics, Inc. KYJ Class II 2009-02-09
K083458 INTRAMEDULLARY FIXATION ROD (IFS) Novalign Orthopaedics, Inc. HSB Class II 2009-02-09
K082371 SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM Smith & Nephew, Inc. LZO Class II 2009-02-09
K082918 MASTERGRAFT RESORBABLE CERAMIC GRANULES Medtronic Sofamor Danek MQV Class II 2009-02-09
K082019 FREEDOM TOTAL KNEE SYSTEM Maxx Orthopedics, Inc. JWH Class II 2009-02-06
K081888 DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE Spineart MAX Class II 2009-02-06
K083447 MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 Memometal Technologies HRS Class II 2009-02-06
K083439 SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM Synthes (Usa) MBF Class II 2009-02-05
K082874 BIODRIVE CANNULATED SCREW SYSTEM Biomet Trauma HWC Class II 2009-02-05
K082833 NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER Nutek Orthopaedics, Inc. KTT Class II 2009-02-05
K083338 CARDIFF ANTERIOR CERVICAL PLATE SYSTEM Seaspine, Inc. KWQ Class II 2009-02-02
K082262 LDR SPINE ROI INTERBODY FUSION SYSTEM Ldr Spine USA MAX Class II 2009-02-02
K090091 OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM Mylad Orthopedic Solutions, LLC HSB Class II 2009-02-01
K081153 NOVEL SPINAL SYSTEM Medyssey Co, Ltd. MNH Class II 2009-01-30
K083635 SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW Smith & Nephew Endoscopy, Inc. MBI Class II 2009-01-30
K083286 ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp. HRS Class II 2009-01-30
K083226 SMITH & NEPHEW PEEK INTERFERENCE SCREW Smith & Nephew Endoscopy, Inc. MBI Class II 2009-01-30
K081548 ANTERIOR BUTTRESS PLATE Scient'X USA, Inc. KWQ Class II 2009-01-29
K083865 PILOT SPINAL SYSTEM Life Spine MNI Class II 2009-01-28
K083279 CALTRIX RESORBABLE BONE VOID FILLER Ag Digital Technology Corp. MQV Class II 2009-01-28
K082754 AEQUALIS HUMERAL NAIL SYSTEM Tornier HSB Class II 2009-01-27
K082504 APOLLO ANTERIOR CERVICAL PLATE SYSTEM Apollo Spine, Inc. KWQ Class II 2009-01-27
K082810 ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW Arthrex, Inc. MAI Class II 2009-01-23
K083826 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC MNH Class II 2009-01-22
K082353 MERCURY SPINAL SYSTEM Spinal Elements, Inc. NKB Class II 2009-01-22
K083151 EXTREMITY MEDICAL SUTURE ANCHOR Extremity Medical, LLC MBI Class II 2009-01-22
K082728 VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2009-01-16
K082617 TRAUSON GENERAL SPINAL SYSTEM (GSS) Trauson (Jiangsu) Medical Instrument Co., Ltd. MNI Class II 2009-01-15
K083495 MODIFICATION TO: METHA HIP SYSTEM Aesculap Implant Systems, Inc. LZO Class II 2009-01-15
K083150 G-FORCE TENODESIS SCREW Wrightmedicaltechnologyinc MBI Class II 2009-01-15
K082996 BIOLOX DELTA OPTION CERAMIC HEADS Biomet, Inc. LZO Class II 2009-01-15
K082406 EXPANDABLE PEEK-OPTIMA IMPLANT Ebi, L.P. MAX Class II 2009-01-14
K083025 SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM Synthes (Usa) HRS Class II 2009-01-14
K083089 NEWPORT SPINAL SYSTEM Seaspine, Inc. NKB Class II 2009-01-13
K081230 TRAUSON INTRAMEDULLARY NAIL Trauson (Jiangsu) Medical Instrument Co., Ltd. HSB Class II 2009-01-13
K083743 CAPSURE PS SYSTEM Spine Wave, Inc. MNI Class II 2009-01-13
K083167 PHENIX CERVICAL INTERBODY DEVICE Spinal Devices, LLC ODP Class II 2009-01-13
K083240 OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES Arthrocare Corp. MBI Class II 2009-01-12
K082231 ASCENSION SILICONE PIP Ascension Orthopedics, Inc. KYJ Class II 2009-01-12
K082466 XYCOR SPINAL IMPLANT Vertebration,Inc MQP Class II 2009-01-09
K083416 REVOLVE STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2009-01-09
K083032 PERI-LOC BONE PLATING AND SCREW SYSTEM Smith & Nephew, Inc. HRS Class II 2009-01-07
K082712 THEKEN SPINE VU EPOD AND VU LPOD SYSTEM Theken Spine, LLC MAX Class II 2009-01-02
K083213 SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES Synthes (Usa) HRS Class II 2008-12-30
K082999 ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART Arthrex, Inc. MAI Class II 2008-12-30
K083026 CLYDESDALE SPINAL SYSTEM Medtronic Sofamor Danek MAX Class II 2008-12-29
K082792 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS Medacta International S.A. JDI Class II 2008-12-29
K082892 REJUVENATE MONOLITHIC HIP SYSTEM Howmedica Osteonics Corp. MEH Class II 2008-12-29
K083232 MODIFICATION TO:MICROFUSE BONE VOID FILLER Globus Medical, Inc. MQV Class II 2008-12-24
K082801 PHANTOM PLUS CAGE SYSTEM Us Spine ODP Class II 2008-12-22
K082926 ZUMA, MODEL 55-XXXX/56-XXXX Seaspine, Inc. OVD Class II 2008-12-22
K081608 PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) Toby Orthopaedics, LLC HRS Class II 2008-12-19
K082729 RIMCLOSE BONE ANCHOR Anulex Technologies, Inc. MBI Class II 2008-12-19

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