meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2013-02-05

Clearances · page 70 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121453 A-GRIX TE RESORABLE BONE VOID FILLER Ag Digital Technology Corp. MQV Class II 2013-02-05
K123362 MILAGRO ADVANCE INTERFERENCE SCREW Depuy Mitek, A Johnson & Johnson Company HWC Class II 2013-02-01
K123578 ANTERIOR CERVICAL PLATE SYSTEM Weigao Orthopaedic Device Co., Ltd. KWQ Class II 2013-02-01
K123134 EASYSPINE SYSTEM Ldr Spine USA, Inc. NKB Class II 2013-02-01
K122853 NOVEL FIT AND FILL STEM Howmedica Osteonics Corp. MEH Class II 2013-02-01
K122081 NUVASIVE LONG LATERAL SPINAL SYSTEM Nuvasive, Inc. KWQ Class II 2013-02-01
K123691 MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) Medtronic Sofamor Danek, Inc. MQV Class II 2013-01-31
K120603 VARILIFT -C Wenzel Spine ODP Class II 2013-01-29
K121670 MEDYSSEY CANNULATED PEDICLE SCREW Medyssey Co, Ltd. NKB Class II 2013-01-25
K123055 SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION Smith & Nephew, Inc. HRS Class II 2013-01-25
K123982 TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ Encore Medical L.P. KWS Class II 2013-01-23
K123401 GAMMA3 AND T2 RECON TARGETING DEVICES Stryker Trauma AG HSB Class II 2013-01-23
K123579 FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL Smith & Nephew, Inc. MBI Class II 2013-01-23
K123281 ACCULIF TL-PEEK CAGE Coalign Innovations, Inc. MAX Class II 2013-01-23
K122310 GEMINUS FOSSA SPECIFIC PLATE SYSTEM Skeletal Dynamics, LLC HRS Class II 2013-01-18
K120464 INNESIS PEEK CAGE Bk Meditech, Co., Ltd. MAX Class II 2013-01-18
K123231 CALIBER SPACERS Globus Medical, Inc. MAX Class II 2013-01-18
K102689 CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM Conventus Orthopaedics HRS Class II 2013-01-17
K121392 NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE Exactech, Inc. LZO Class II 2013-01-16
K122870 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2013-01-14
K123752 ACCULIF TL AND PL CAGE Coalign Innovations, Inc. MAX Class II 2013-01-14
K121254 CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE Camber Spine Technologies MAX Class II 2013-01-11
K121313 MTF NEW BONE VOID FILLER Musculoskeletal Transplant Foundation MQV Class II 2013-01-11
K123342 OPTETRAK LOGIC CRC TIBIAL INSERT Exactech, Inc. JWH Class II 2013-01-10
K122771 SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Spinal Elements, Inc. OVE Class II 2013-01-10
K123441 STRYKER CROSSFLOW ARTHROSCOPY PUMP Stryker Endoscopy HRX Class II 2013-01-09
K122336 Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM Eleven Blade Solutions, Inc. MBI Class II 2013-01-09
K123180 FALCON SPACER Synthes (USA) Products, LLC MAX Class II 2013-01-08
K122698 AEQUALIS ASCEND FLEX SHOULDER SYSTEM Tornier S.A.S. KWS Class II 2013-01-08
K121261 ASAP MUITISCOPE Asap Endoscopic Products GmbH HRX Class II 2013-01-08
K123476 MEGA 5.5 SPINE SYSTEM Lsk Biopartners, Inc. MNH Class II 2013-01-08
K122592 INSTINCT JAVA SYSTEM Zimmer Spine MNH Class II 2013-01-04
K123388 K7C SPACER K7, LLC ODP Class II 2013-01-04
K123363 SUPER STAPLE(TM) CLASSIC Metric Medical Devices, Inc. JDR Class II 2013-01-03
K121297 ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR Signature Orthopaedics Pty, Ltd. LPH Class II 2012-12-28
K123167 DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM Medos International SARL KWQ Class II 2012-12-28
K121693 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) Sapphire Medical Group, Inc. MAX Class II 2012-12-27
K122134 FLEXLITE CAMERA Spine View, Inc. HRX Class II 2012-12-27
K123000 INTEGRA TOTAL FOOT SYSTEMS Integra LifeSciences Corporation HRS Class II 2012-12-21
K112898 DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS Lima Corporate S.P.A. LPH Class II 2012-12-21
K123771 KYPHON EXPRESS II INFLATABLE BONE TAMPS Medtronic HRX Class II 2012-12-21
K123341 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON Arthrex, Inc. MBI Class II 2012-12-21
K123093 STABILINK MIS SPINAL FIXATION SYSTEM Southern Spine, LLC KWP Class II 2012-12-20
K122991 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2012-12-20
K122975 GKS PRIME FLEX CR TOTAL KNEE SYSTEM Permedica JWH Class II 2012-12-20
K122208 EXTERNAL FIXATOR SYSTEM Christopher D. Endara NDK Class II 2012-12-20
K122954 CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 Foundry Newcoxi, Inc. MBI Class II 2012-12-19
K123568 VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2012-12-18
K122509 VERTIFLEX SPINOUS PROCESS FIXATION PLATE Vertiflex, Inc. KWP Class II 2012-12-17
K120955 COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM Aesculap Implant Systems, LLC JWH Class II 2012-12-17
K123203 MAXLOCK EXTREME SYSTEM MODEL MXL Orthohelix Surgical Designs, Inc. HRS Class II 2012-12-14
K121514 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM Corelink, LLC KWQ Class II 2012-12-14
K100404 ASCENDX VCF REDUCTION SYSTEM Aoi Medical, Inc. NDN Class II 2012-12-14
K122869 MILAGRO INTERFERENCE SCREWS Depuy Mitek, A Johnson & Johnson Company MAI Class II 2012-12-13
K122571 MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM Seaspine, Inc. NKB Class II 2012-12-12
K123352 S4 SPINAL SYSTEM Aesculap Implant Systems, Inc. NKB Class II 2012-12-12
K120356 NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD Ncs Lab Srl MBI Class II 2012-12-11
K122158 PBP TOTAL HIP SYSTEM Pipeline Biomedical Products, LLC OQG Class II 2012-12-11
K122489 EMERGE MEDICAL SOLID BONE SCREWS Emerge Medical HWC Class II 2012-12-10
K122845 ES2 SPINAL SYSTEM MODEL 48280XXXX Stryker Spine NKB Class II 2012-12-07
K122861 XTOOL Ouroboros Medical HRX Class II 2012-12-07
K121495 LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG Aap Implantate AG HRS Class II 2012-12-07
K122733 V2F ANTERIOR FIXATION SYSTEM Zimmer Spine, Inc. KWQ Class II 2012-12-07
K121067 EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE Exactech, Inc. PHX Class II 2012-12-06
K122097 PATRIOT SPACERS Globus Medical, Inc. MAX Class II 2012-12-06
K122630 IN:C2 SPINAL FIXATION SYSTEM Spine Smith Partners L.P. OVE Class II 2012-12-05
K122745 ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM Zimmer, Inc. MBH Class II 2012-12-05
K121640 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM Materialise NV JWH Class II 2012-12-05
K122814 GALLEON PEDICLE SCREW SYSTEM Everest Spine, LLC MNH Class II 2012-12-03
K122692 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS Zimmer, Inc. PHX Class II 2012-12-03
K123451 POLARIS SPINAL SYSTEM - BALLISTA II RODS Biomet Spine (Aka Ebi, LLC) NKB Class II 2012-12-03
K122901 FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM Orthofix NKB Class II 2012-12-03
K121649 CONSTRUX MINI PEEK TI SPACER SYSTEM Orthofix ODP Class II 2012-11-29
K123207 PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM Osteomed LP MAX Class II 2012-11-29
K122334 CHECKMATE SMALL BONE FUSION SYSTEM Arthrosurface, Inc. HRS Class II 2012-11-28
K121989 OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, Exactech, Inc. MQV Class II 2012-11-27
K120787 MERETE LOCKING BONE PLATE SYSTEM III Merete Medical GmbH HRS Class II 2012-11-27
K120651 STABILIZ FIXATION SYSTEM Stabiliz Orthopaedics, LLC HRS Class II 2012-11-27
K120409 PICCOLO COMPOSITE PLATE SYSTEM CarboFix Orthopedics , Ltd. HRS Class II 2012-11-26
K121874 G7 ACETABULAR SYSTEM Biomet Manufacturing Corp PBI Class II 2012-11-23
K122305 CORIN TRINITY-I ACETABULAR SHELL Corin USA LZO Class II 2012-11-21
K122931 S-LOK PSS SYSTEM Spinal USA MNI Class II 2012-11-20
K122596 ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS Smith & Nephew, Inc. HWC Class II 2012-11-20
K121220 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT Exactech, Inc. KWS Class II 2012-11-20
K122229 VICEROY SPINAL SYSTEM Torrey Spine NKB Class II 2012-11-20
K123297 COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM Biomet Manufactuting Corp. MBF Class II 2012-11-20
K121791 ZOU ANTERIOR LUMBAR PLATE SYSTEM Corelink, LLC KWQ Class II 2012-11-19
K121494 LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING Aap Implantate AG HRS Class II 2012-11-19
K122538 ACUMED PELVIC BONE PLATE SYSTEM Acumed, LLC HRS Class II 2012-11-19
K122008 INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE Incite Innovation, LLC OVE Class II 2012-11-16
K122529 ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE Zimmer, Inc. HSX Class II 2012-11-16
K123246 CD HORIZON SPIRE Z SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2012-11-16
K121151 PRO-LINK CERVICAL SPACER SYSTEM Life Spine, Inc. OVE Class II 2012-11-16
K113728 SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY Hans Biomed Corp. MBP Class II 2012-11-15
K122860 KLS MARTIN RECON TALON KLS Martin L.P. HRS Class II 2012-11-14
K122662 VERTIFLEX DIRECT DECOMPRESSION SYSTEM Vertiflex, Inc. HRX Class II 2012-11-13
K121354 MICRO/MINI N-PK(F) BONE ANCHOR Anulex Technologies, Inc. MBI Class II 2012-11-09
K121356 MICRO/MINI N-PK(H) BONE ANCHOR Anulex Technologies, Inc. MBI Class II 2012-11-09
K112091 H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS Lima Corporate S.P.A. MEH Class II 2012-11-09
K122765 PERSONA NATURAL TIBIA BASEPLATES Zimmer, Inc. JWH Class II 2012-11-09

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