meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2013-08-23

Clearances · page 67 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K131878 LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM Medyssey USA, Inc. NKB Class II 2013-08-23
K131374 TEMPUS(TM) CERVICAL PLATE SYSTEM Neurostructures, LLC KWQ Class II 2013-08-23
K131310 GMK FULL PE TIBIAL COMPONENTS Medacta International JWH Class II 2013-08-22
K132332 MOUNTAINEER OCT SPINAL SYSTEM Medos International SARL KWP Class II 2013-08-22
K131884 AVENIR CEMENTED HIP STEM Zimmer GmbH LZO Class II 2013-08-22
K131657 FLOWER SMALL AND MEDIUM IMPLANT SET Flower Orthopedics Corporation HRS Class II 2013-08-22
K130627 SWING-OFF SCREW Advanced Interventional Technology, LLC HWC Class II 2013-08-21
K131785 PAGODA PEDICLE SCREW SYSTEM Ortho Development Corp. NKB Class II 2013-08-20
K131129 CAS PSI SHOULDER Zimmer Cas KWS Class II 2013-08-20
K132365 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION Accel Spine MNI Class II 2013-08-20
K131071 STAXX IBL SYSTEM Spine Wave, Inc. MAX Class II 2013-08-20
K131325 QUATTRO GL SUTURE ANCHOR Cayenne Medical, Inc. MBI Class II 2013-08-16
K123604 ABG III MONOLITHIC HIP STEM Howmedica Osteonics Corp. MAY Class II 2013-08-16
K130299 GMK HINGE Medacta International KRO Class II 2013-08-15
K130832 ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. JDR Class II 2013-08-15
K130392 KINEX BIOACTIVE Globus Medical, Inc. MQV Class II 2013-08-15
K130948 C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Southern Spine, LLC ODP Class II 2013-08-14
K131951 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM X-Spine Systems, Inc. OVE Class II 2013-08-14
K123814 HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions KWT Class II 2013-08-13
K131133 VIVORTE BVF LITE Vivorte, Inc. MQV Class II 2013-08-12
K130089 CROSSTREES PVA POD Crosstrees Medical, Inc. NDN Class II 2013-08-09
K132154 CAPSURE PS SYSTEM Spine Wave, Inc. MNI Class II 2013-08-09
K132226 METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT Merete Medical GmbH HRS Class II 2013-08-09
K124014 SUREFIX INTERSPINOUS FUSION SYSTEM Jg Spine, LLC PEK Class II 2013-08-09
K131279 ICONACY I-HIP SYSTEM Iconacy Orthopedic Implants, LLC LPH Class II 2013-08-09
K131522 CORE PEDICLE SCREW SYSTEM Core-Nexus MNI Class II 2013-08-09
K131759 METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM Tianjin Walkman Biomaterial Co., Ltd. HRS Class II 2013-08-08
K130820 EXPANDABLE LUMBAR INTERBODY SYSTEM Nu Vasive, Incorporated MAX Class II 2013-08-08
K131810 OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM Osseus Fusion Systems, LLC MNH Class II 2013-08-08
K131538 CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM Captiva Spine MNH Class II 2013-08-08
K130932 FIREBIRD SPINAL FIXATION SYSTEM Orthofix, Inc. NKB Class II 2013-08-07
K131360 INTEGRA TITANIUM BONE WEDGE Ascension Orthopedic HRS Class II 2013-08-07
K131512 KATIA SYSTEM Shanghai Sanyou Medical Co, Ltd. KWQ Class II 2013-08-07
K131722 I.T.S. EXTREMITY FIXATION SYSTEMS I.T.S. GmbH HRS Class II 2013-08-07
K132111 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA NKB Class II 2013-08-06
K130126 SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM Biomet, Inc. MBF Class II 2013-08-06
K122883 EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM Stelkast Company JWH Class II 2013-08-05
K123347 NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 Normed Medizin-Technik GmbH HRS Class II 2013-08-02
K130033 TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO Biomet Manufacturing Corp MBI Class II 2013-08-01
K130814 RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM Depuy Mitek, A Johnson & Johnson Company MBI Class II 2013-08-01
K131449 COALITION SPACER Globus Medical, Inc. OVE Class II 2013-07-30
K130302 SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT Spinevision S.A. MNI Class II 2013-07-30
K131182 MULTIFIX S KNOTLESS FIXATION DEVICE Arthocare Corporation MBI Class II 2013-07-29
K131264 KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS Gebr. Brasseler GmbH & Co. KG HWC Class II 2013-07-26
K123721 GMK REVISION EXTENSION Medacta International JWH Class II 2013-07-26
K130478 SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS Globus Medical, Inc. MAX Class II 2013-07-26
K131974 HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) Depuy Mitek, A Johnson & Johnson Company MAI Class II 2013-07-25
K130859 HAMMERTOE CORRECTION SYSTEM Arthrosurface, Inc. HWC Class II 2013-07-25
K130431 COMPRESSYN BAND Dallen Medical, Inc. JDQ Class II 2013-07-25
K131620 JONES-FX FRACTURE SYSTEM Instratek, Inc. HWC Class II 2013-07-25
K123027 CAPSTONE(R) SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MAX Class II 2013-07-25
K131343 REFORM PEDICLE SCREW SYSTEM Spinal USA MNI Class II 2013-07-24
K130986 FRAG-LOC SYSTEM Acumed, LLC HTN Class II 2013-07-23
K131191 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS Depuy Mitek, A Johnson & Johnson Company HRX Class II 2013-07-22
K130731 STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW Stabiliz Orthopaedics, LLC HRS Class II 2013-07-19
K131467 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2013-07-18
K131077 LIFE SPINE PLATEAU SPACER SYSTEM Life Spine MAX Class II 2013-07-17
K130953 NEOTIS; NEOTIS 50 Sbm Sciences For Bio Materials MQV Class II 2013-07-15
K130051 611 ANKLE FUSION NAIL Tornier S.A.S. HSB Class II 2013-07-15
K131547 LANX FUSION SYSTEM Lanx, Inc. OVD Class II 2013-07-12
K131520 NEXUS ANTERIOR CERVICAL PLATE SYSTEM Core-Nexus KWQ Class II 2013-07-11
K124045 FUSEFORCE IMPLANT SYSTEM Solana Surgical, LLC JDR Class II 2013-07-10
K131671 MECTALIF Medacta International MAX Class II 2013-07-05
K121178 TRANSCORP ACIF SYSTEM Transcorp, Inc. ODP Class II 2013-07-05
K131283 PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc HSN Class II 2013-07-05
K131670 LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) Biomet, Inc. HRS Class II 2013-07-03
K131480 EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM Emerge Medical HRS Class II 2013-07-03
K131474 ARTHREX DISTAL RADIUS PLATE SYSTEM Arthrex, Inc. HRS Class II 2013-07-03
K131575 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT Exactech, Inc. PHX Class II 2013-07-03
K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC Wrightmedicaltechnologyinc LZO Class II 2013-07-03
K131238 AFFIX SPINOUS PROCESS PLATE SYSTEM Nuvasive, Inc. PEK Class II 2013-07-02
K131372 MOBIS II Signus Medizintechnik GmbH MAX Class II 2013-07-02
K131035 Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM Linvatec Corporation D/B/A Conmed Linvatec MBI Class II 2013-07-02
K130353 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) Pipeline Orthopedics LPH Class II 2013-07-01
K123598 SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION Smith & Nephew, Inc. JDI Class II 2013-06-28
K131100 STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc. NKB Class II 2013-06-27
K131683 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) Depuy Mitek, Inc., A Johnson and Johnson Company MBI Class II 2013-06-27
K130438 AXLE INTERSPINOUS FUSION SYSTEM X-Spine Systems, Inc. PEK Class II 2013-06-27
K122503 PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON Neuro Therm, Inc. NDN Class II 2013-06-25
K131005 EBA2 FEMORAL NAILING SYSTEM Citieffe S.R.L. HSB Class II 2013-06-25
K130008 DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING I.T.S. GmbH HRS Class II 2013-06-25
K122957 TEZO TITANIUM CAGE FAMILY Ulrich GmbH & Co. KG MAX Class II 2013-06-21
K130099 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 Encore Medical L.P. LPH Class II 2013-06-21
K130279 REFORM PEDICLE SCREW SYSTEM Spinal USA MNI Class II 2013-06-20
K130877 EXPEDIUM SPINE SYSTEM Medos International SARL NKB Class II 2013-06-20
K130217 ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM OrthoPediatrics Corp. MBI Class II 2013-06-20
K130774 UNIVERSAL DISTAL RADIUS SYSTEM Newclip Technics HRS Class II 2013-06-19
K131443 COALIGN INNOVATIONS ACCULIF XL IBF CAGE Coalign Innovations, Inc. MAX Class II 2013-06-19
K130050 TITAN REVERSE SHOULDER SYSTEM Ascension Orthopedic KWS Class II 2013-06-18
K130298 BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM Biopro, Inc. JDW Class II 2013-06-18
K131445 OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM Osteomed LP HRS Class II 2013-06-18
K123810 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CarboFix Orthopedics , Ltd. HSB Class II 2013-06-14
K130912 OMNICUT RESECTION BLADE Depuy Mitek, A Johnson & Johnson Company HRX Class II 2013-06-14
K130630 PLATEAU SPACER SYSTEM TITANIUM Life Spine, Inc. MAX Class II 2013-06-13
K131237 PIPELINE TOTAL HIP SYSTEM Pipeline Orthopedics LPH Class II 2013-06-13
K130642 SMR 3-PEGS GLENOIDS Lima Corporate S.P.A. KWS Class II 2013-06-12
K122588 VUSION CS PLUS Ortho Development Corp. ODP Class II 2013-06-12
K130907 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Trauma AG KTT Class II 2013-06-10
K131380 ACUMED TOTALW RIST FUSION PLATING SYSTEM Acumed, LLC HRS Class II 2013-06-10
K131112 LIMACORPORATE SMR CTA HUMERAL HEADS Lima Corporate S.P.A. KWS Class II 2013-06-07

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