meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2005-07-13

Clearances · page 106 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051146 TRIATHLON KNEE SYSTEM Howmedica Osteonics Corp. JWH Class II 2005-07-13
K051663 MALIBU SPINAL SYSTEM Seaspine, Inc. NKB Class II 2005-07-12
K051588 BIOLOX DELTA CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. LZO Class II 2005-07-12
K051412 HUMERAL HEAD PLATE WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2005-07-11
K051155 SOLCO 4CIS GENERAL PLATE SYSTEM Solco Biomedical Co., Ltd. HRS Class II 2005-07-11
K051309 ROI FUSION RODS & PLATES Reiley Orthopaedics, Inc. HWC Class II 2005-07-11
K050855 PALAMED G Heraeus Kulzer,GmbH LOD Class II 2005-07-07
K051098 PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES Zimmer, Inc. HWC Class II 2005-07-07
K050966 PIVOT BIPOLAR FEMORAL HEAD Ortho Development Corp. KWY Class II 2005-07-07
K050449 QUANTUM VERTEBRAL BODY REPLACEMENT Quantum Orthopedics, Inc. MQP Class II 2005-07-07
K051323 MERETE TWISTCUT SNAP-OFF BONE SCREW Merete Medical GmbH HWC Class II 2005-07-07
K050690 CONNEXUS Isotis Orthobiologics, Inc. MQV Class II 2005-07-07
K050854 PALACOS LV+G Heraeus Kulzer,GmbH LOD Class II 2005-07-07
K051624 T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2005-07-07
K051024 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2005-07-06
K051557 TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS Smith & Nephew, Inc. JDS Class II 2005-06-30
K051491 TRABECULAR METAL PRIMARY HIP PROSTHESIS Zimmer, Inc. LPH Class II 2005-06-30
K043479 MC+ PARTIAL VBR Ldr Spine USA MQP Class II 2005-06-30
K051411 ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS Biomet, Inc. LZO Class II 2005-06-29
K043349 OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) Ldr Spine USA MQP Class II 2005-06-29
K051017 R-X-FIX EXTERNAL FIXATOR R-X-Fix KTT Class II 2005-06-29
K050441 TAPER 2 POROUS FEMORAL STEM Biomet, Inc. JDI Class II 2005-06-29
K051027 STALIF TT Surgicraft , Ltd. MQP Class II 2005-06-29
K051408 INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS Intelifuse, Inc. JDR Class II 2005-06-29
K051219 PUSHLOCK Arthrex, Inc. MAI Class II 2005-06-29
K051554 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2005-06-29
K051069 NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER Arthrotek, Inc. MBI Class II 2005-06-29
K051363 RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. JDI Class II 2005-06-23
K041177 SYNTHACER; SYNTRICER Medartis Medizinprodukte Und Forschung AG MQV Class II 2005-06-23
K050830 ZODIAC SPINAL FIXATION SYSTEM Alphatec/Nexmed KWP Class II 2005-06-22
K050852 CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2005-06-22
K051335 ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS Exactech, Inc. JDI Class II 2005-06-21
K051286 ZODIAC SPINAL FIXATION SYSTEM Alphatec/Nexmed MNH Class II 2005-06-17
K043176 ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM Arc Surgical, LLC HWC Class II 2005-06-17
K051306 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. LXT Class II 2005-06-17
K050864 PARALLAX ACRYLIC RESIN WITH TRACERS TA Arthrocare Corp. NDN Class II 2005-06-17
K051196 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 Implex Corp. MQP Class II 2005-06-17
K051326 SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM Smith & Nephew, Inc. HRX Class II 2005-06-15
K050809 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2005-06-14
K051246 CONSTRUX MINI PEEK VBR SYSTEM Blackstone Medical, Inc. MQP Class II 2005-06-14
K050965 TRANS1 AXIALIF SYSTEM Trans1 Incorporated KWQ Class II 2005-06-14
K043548 BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM Blackstone Medical, Inc. KWQ Class II 2005-06-14
K050767 STERLING INTERFERENCE SCREW ST Regeneration Technologies, Inc. HWC Class II 2005-06-09
K051250 AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. MAI Class II 2005-06-09
K042415 MENDEC SPINE Tecres S.P.A. NDN Class II 2005-06-09
K051105 BASIS VERTEBRAL BODY SPACER Medtronic Sofamor Danek MQP Class II 2005-06-09
K050082 CENTERPIECE PLATE FIXATION SYSTEM Medtronic Sofamor Danek, Inc. NQW Class II 2005-06-06
K051123 CALLOS IMPACT AND INJECT BONE VOID FILLER Skeletal Kinetics, LLC MQV Class II 2005-06-03
K051086 SMITH & NEPHEW PATELLO-FEMORAL IMPLANT Smith & Nephew, Inc. KRR Class II 2005-05-31
K050924 MERETE DUOTHREADTM BONE SCREW Merete Medical GmbH HWC Class II 2005-05-27
K050861 PEEK CAS Interpore Cross Intl. MQP Class II 2005-05-27
K050259 ARTHREX BIO-PIN Arthrex, Inc. HTY Class II 2005-05-27
K050789 FORMAGRAFT COLLAGEN BONE GRAFT MATRIX R and D Medical, LLC MQV Class II 2005-05-27
K050348 CO VERTEBRAL BODY REPLACEMENT Scient'X MQP Class II 2005-05-27
K051075 ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P. PHX Class II 2005-05-27
K050251 BALANCE HIP SYSTEM Biomet, Inc. KWA Class III 2005-05-27
K050868 MAXLOCK Orthohelix Surgical Designs, Inc. HRS Class II 2005-05-27
K050882 NEWDEAL ANKLE NAIL New Deal, S.A. HSB Class II 2005-05-27
K050850 XPAND CORPECTOMY SPACER Globus Medical, Inc. MQP Class II 2005-05-26
K051181 CUSTOM-HIP TOOL Orthopedic Sciences, Inc. HRS Class II 2005-05-23
K051063 POLYAXIAL HEMISPHERICAL SPINAL SCREWS Scient'X MNI Class II 2005-05-23
K051032 TITANIUM-HIP TOOL Orthopedic Sciences, Inc. HRS Class II 2005-05-23
K051000 FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE Spinal Concepts, Inc. MQP Class II 2005-05-19
K043542 BIOPRO TARA FEMORAL RESURFACING COMPONENT Biopro, Inc. KXA Class II 2005-05-18
K050754 PRECIMED CANNULATED SCREW SYSTEM Precimed, Inc. HWC Class II 2005-05-18
K050058 THEKEN REVEAL VBR SYSTEM Theken Surgical,Llc MQP Class II 2005-05-17
K050981 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MNI Class II 2005-05-17
K050105 NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS Zimmer, Inc. JDI Class II 2005-05-17
K043484 LANX SPINAL FIXATION SYSTEM Lanx, LLC MNI Class II 2005-05-16
K050315 DELTA HUMERAL CUPS DePuy Orthopaedics, Inc. PHX Class II 2005-05-16
K050471 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. MNH Class II 2005-05-12
K051039 BASIS SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. KWQ Class II 2005-05-12
K050749 ARTHREX TAK FAMILY Arthrex, Inc. HWC Class II 2005-05-12
K051083 ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM Acumed, LLC HRS Class II 2005-05-12
K050892 HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM Blackstone Medical, Inc. KWQ Class II 2005-05-11
K043518 RADIOPAQUE BONE CEMENT Cardinalhealth NDN Class II 2005-05-11
K050556 ALUMINA HEAD Fournitures Hospitalieres Industrie LZO Class II 2005-05-11
K050937 TRABECULAR METAL ACETABULAR REVISION SHELLS Zimmer Trabecular LPH Class II 2005-05-11
K050938 KNEE FUSION NAIL Smith & Nephew, Inc. JDS Class II 2005-05-04
K043073 PROCOTYL-E ACETABULAR SYSTEM Wrightmedicaltechnologyinc KWA Class III 2005-05-04
K050060 LAGUNA PEDICLE SCREW SYSTEM Allez Spine, LLC MNI Class II 2005-05-04
K050484 BASIS SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2005-05-04
K050849 HA COATED LAG SCREW Smith & Nephew, Inc. KTT Class II 2005-05-04
K050813 ABC 2 SCREW Aesculap, Inc. KWQ Class II 2005-05-04
K043005 MODIFICATION TO MBCP Biomatlante MQV Class II 2005-05-03
K042989 RX90 LOW PROFILE ACETABULAR SYSTEM Biomet, Inc. LPH Class II 2005-04-28
K050683 SYNTHES (USA) 3.5MM CONICAL SCREWS Synthes (Usa) HWC Class II 2005-04-27
K050462 SBI HAND FIXATION SYSTEM (TM) Small Bone Innovations, LLC HRS Class II 2005-04-26
K050646 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES Synthes (Usa) HRS Class II 2005-04-26
K050932 DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM Hand Innovations, Inc. LXT Class II 2005-04-26
K050588 VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM Innovative Spinal Design, LLC KWQ Class II 2005-04-21
K050636 SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS Synthes (Usa) HWC Class II 2005-04-21
K050357 CAMCERAM TCP Cam Implants B.V. MQV Class II 2005-04-21
K050580 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS Smith & Nephew Endoscopy, Inc. HRX Class II 2005-04-20
K050723 MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. JWH Class II 2005-04-20
K043083 ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL Wrightmedicaltechnologyinc MBH Class II 2005-04-18
K043339 REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG Xtremi-T, LLC HTY Class II 2005-04-18
K043356 WAGNER SL REVISION STEM LATERAL Zimmer Austin, Inc. LZO Class II 2005-04-18
K050553 NOVEL VBR SPINAL SYSTEM Alphatec/Nexmed MQP Class II 2005-04-18
K050358 ARTHERX CORKSCREW FT II SUTURE ANCHOR Arthrex, Inc. HWC Class II 2005-04-15

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