meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2008-05-06

Clearances · page 93 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K080980 EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS Exactech, Inc. MEH Class II 2008-05-06
K080009 NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT Novabone Products, LLC MQV Class II 2008-05-06
K081007 ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM Zimmer, Inc. KWA Class III 2008-05-06
K080646 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM Biomet Spine KWQ Class II 2008-05-02
K080963 DSS STABILIZATION SYSTEM Paradigm Spine NQP Class II 2008-05-02
K073281 CAIS STAPLE Depuy Mitek, A Johnson & Johnson Company JDR Class II 2008-05-02
K080065 OSFERION Olympus Terumo Biomaterials Corporation MQV Class II 2008-05-02
K081071 SYNTHES 6.5MM MIDFOOT FUSION BOLT Synthes (Usa) HWC Class II 2008-05-01
K080568 X-MESH EXPANDABLE CAGE SYSTEM Depuy Spine, Inc. MQP Class II 2008-05-01
K080281 PATHWAY Custom Spine, Inc. MAX Class II 2008-05-01
K071983 AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE Aesculap Implant Systems, Inc. MAX Class II 2008-05-01
K080429 MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM Medtronic Sofamor Danek USA, Inc. KWQ Class II 2008-04-30
K080928 XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS Stryker Spine NKB Class II 2008-04-30
K080790 MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC KWP Class II 2008-04-29
K073643 TRANS1 AXIALIF 2-LEVEL OR II SYSTEM Trans1 Incorporated KWQ Class II 2008-04-28
K080885 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION Medacta International S.A. JDI Class II 2008-04-28
K080329 CAP PLUS, EQUIVABONE, CAP/DBM Etex Corp. MBP Class II 2008-04-28
K080408 EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD Advanced Orthopaedic Solutions, Inc. KTT Class II 2008-04-25
K080690 MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM Theken Spine, LLC KWQ Class II 2008-04-25
K073291 CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2008-04-24
K073440 FOUNDATION CAGE Corelink, LLC MAX Class II 2008-04-24
K080943 SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS Synthes (Usa) HWC Class II 2008-04-23
K080815 TOSCA II ANTERIOR CERVICAL PLATE SYSTEM Signus Medizintechnik GmbH KWQ Class II 2008-04-23
K080358 PLLA, HA SCREW Smith & Nephew Inc., Endoscopy Div. HWC Class II 2008-04-23
K080335 TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM Tornier, Inc. MBI Class II 2008-04-23
K080511 PLEXUR-P Osteotech, Inc. MQV Class II 2008-04-21
K080361 REGENEREX TIBIAL COMPONENTS Biomet, Inc. MBH Class II 2008-04-21
K080805 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2008-04-18
K071261 ISOBAR SEMI-RIGID DUAL DAMPENER Scient'X NQP Class II 2008-04-17
K072729 SIERRA Seaspine, Inc. KWP Class II 2008-04-17
K080058 TURBO PRIME IBD SYSTEM Spineselect, LLC MAX Class II 2008-04-16
K080526 SIERRA SYSTEM Seaspine, Inc. KWP Class II 2008-04-16
K080736 ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE Apatech , Ltd. MQV Class II 2008-04-16
K062691 COMPORUS Takiron Co., Ltd. MQV Class II 2008-04-15
K080850 DARCO HEADLESS COMPRESSION SCREW Wrightmedicaltechnologyinc HWC Class II 2008-04-10
K080434 INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW Smith & Nephew, Inc. JDO Class II 2008-04-10
K080083 INTREPID SPINAL SYSTEM Medtronic Sofamor Danek MAX Class II 2008-04-10
K080099 PASS SPINAL SYSTEM Medicrea Technologies MNI Class II 2008-04-09
K080502 MODIFICATION TO:PILOT SPINAL SYSTEM Life Spine MNI Class II 2008-04-08
K080663 PROFEMUR LX REVISION 5/8 COATED HIP STEM Wrightmedicaltechnologyinc KWA Class III 2008-04-08
K080792 K2M COCR ROD K2m, Inc. MNI Class II 2008-04-08
K080572 LDR SPINE ROI-A IMPLANT Ldr Spine USA MQP Class II 2008-04-07
K073143 MODIFIED VERTIFLEX SPINAL SCREW SYSTEM Vertiflex, Inc. MNI Class II 2008-04-07
K072170 WELLGRAFT PE II Gwowei Technology Co., Ltd. MQV Class II 2008-04-04
K072444 WELLGRAFT PE I Gwowei Technology Co., Ltd. MQV Class II 2008-04-04
K073364 EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2008-04-04
K080191 EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2008-04-02
K073278 SPINOUS PROCESS PLATE SYSTEM Nuvasive, Inc. KWP Class II 2008-03-28
K080402 ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 Encore Medical L.P. KWS Class II 2008-03-28
K080758 AVS PL PEEK SPACERS, MODELS 48351 AND 48353 Stryker Corp. MAX Class II 2008-03-27
K080184 DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2008-03-26
K080101 AAP CANNULATED SCREW AND DARCO HEADED SCREW Aap Implantate AG HWC Class II 2008-03-25
K072321 BIOFLEX Biospine Co., Ltd. NQP Class II 2008-03-25
K073502 VERTEBRON VBR SYSTEM Vertebron, Inc. MQP Class II 2008-03-24
K073674 BONE FIXATION WIRE (KIRSCHNER WIRE) Signal Medical Corp. HTY Class II 2008-03-24
K080302 CAYMAN BUTTRESS PLATE SYSTEM K2m, Inc. KWQ Class II 2008-03-24
K072116 SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM Neurospine Innovations and Solutions NKB Class II 2008-03-20
K073240 PSS SYSTEM Spinal USA MNI Class II 2008-03-20
K072411 AAP BONE PLATES AND SCREW IMPLANTS Aap Implantate AG HRS Class II 2008-03-20
K080518 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology NKB Class II 2008-03-20
K080504 PIONEER LOWTOP SPINAL ROD SYSTEM Pioneer Surgical Technology NKB Class II 2008-03-20
K073637 PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS Biomet Manufacturing Corp KWA Class III 2008-03-20
K080204 VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS Biomet, Inc. JWH Class II 2008-03-20
K073624 MODULAR FOOT SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2008-03-20
K080109 SYNTHES (USA) MODULAR BLADE PLATE SYSTEM Synthes (Usa) KTW Class II 2008-03-20
K073635 SBI SR MTP TOE IMPLANT Small Bone Innovations, Inc. KWD Class II 2008-03-19
K080667 VARIAX DISTAL RADIUS TORX SCREWS Howmedica Osteonics Corp. HRS Class II 2008-03-19
K080560 HENKE SASS WOLF OF AMERICA ARTHROSCOPE Henke Sass Wolf of America, Inc. HRX Class II 2008-03-18
K080280 SUB-TALAR LOK, MODEL 7-11 MM Instratek, Inc. HWC Class II 2008-03-14
K073567 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES Zimmer GmbH LZO Class II 2008-03-13
K080407 BLACKSTONE SFS PARALLEL ROD CONNECTORS Blackstone Medical, Inc. MNI Class II 2008-03-13
K080394 BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM Blackstone Medical, Inc. KWP Class II 2008-03-13
K080352 MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE Depuy Mitek, A Johnson & Johnson Company HWC Class II 2008-03-12
K073064 GRAFTYS BCP Graftys MQV Class II 2008-03-11
K080258 MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. NKB Class II 2008-03-10
K063157 MERRIES K-PHATE BONE GRAFT SUBSTITUTE Merries International, Inc. MQV Class II 2008-03-10
K080349 KIMBA MINI Signus Medizintechnik GmbH MQP Class II 2008-03-10
K072212 JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE Smith & Nephew, Inc. KTT Class II 2008-03-07
K071723 ZIMMER POROLOCK MIS STEM Zimmer GmbH KWA Class III 2008-03-07
K073286 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM Zimmer, Inc. JWH Class II 2008-03-07
K073470 AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX Stryker Spine MAX Class II 2008-03-06
K073509 TWINFIX PK FP SUTURE ANCHOR Smith & Nephew, Inc. HWC Class II 2008-03-04
K073405 PLEXUR M Osteotech, Inc. MQV Class II 2008-03-03
K073402 SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM Synthes (Usa) HSB Class II 2008-02-29
K073228 DC ULNAR SHORTENING SYSTEM Orthopro, LLC HRS Class II 2008-02-29
K080229 5.5 MM SUTURE LOCK BONE SCREW ANCHOR Kfx Medical MBI Class II 2008-02-29
K073120 ACCIN PATELLOFEMORAL SYSTEM Accelerated Innovation, LLC KRR Class II 2008-02-29
K073688 EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW Exactech, Inc. PHX Class II 2008-02-29
K073329 SYGNAL DBM Musculoskeletal Transplant Foundation MBP Class II 2008-02-28
K073150 APEX-LNK POLY ACETABULAR CUP LINERS Omni Life Science, Inc. LPH Class II 2008-02-27
K080295 CHARLOTTE CLAW 3.5 Wrightmedicaltechnologyinc HRS Class II 2008-02-27
K073570 DEPUY TRI-LOCK BONE PRESERVATION STEM DePuy Orthopaedics, Inc. LZO Class II 2008-02-21
K073460 SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES Synthes (Usa) HRS Class II 2008-02-21
K073065 OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM Osteomed LP KWD Class II 2008-02-21
K071809 ENSPLINTRX BONE FIXATION SYSTEM Sonoma Orthopedic Products, Inc. HRS Class II 2008-02-21
K073375 NEWDEAL TIBIAXYS SYSTEM Newdeal Sas HRS Class II 2008-02-21
K073232 INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX Spinefrontier, Inc. KWQ Class II 2008-02-20
K073344 ORTHOPEDIATRICS PLATING SYSTEM Orthopediatrics, LLC HRS Class II 2008-02-19
K073426 APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM Cayenne Medical, Inc. HWC Class II 2008-02-19
K072704 UNICOMPARTMENTAL KNEE Valpo Orthopedic Technology, Inc. HRY Class II 2008-02-19

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