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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
RETROGRADE FEMORAL NAIL (K132005)Advanced Orthopaedic Solutions, Inc.2013-09-10
TIGER SPINE SYSTEM (K131250)Corelink, LLC2013-09-10
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST (K132324)Medos International SARL2013-09-06
COMPREHENSIVE REVERSE SHOULDER SCREWS (K132239)Biomet Manufacturing Corp2013-09-06
ARIX FOOT SYSTEM (K131311)Jeil Medical Corporation2013-09-05
ACUMED WRIST SPANNING PLATE (K131764)Acumed, LLC2013-09-05
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM (K131980)Zimmer Spine, Inc.2013-09-04
POLARIS SPINAL SYSTEM (K131615)Biomet Spine (Aka Ebi, LLC)2013-09-04
INTEGRA INTERSPINOUS PROCESS SYSTEM (K121924)Seaspine, Inc.2013-09-04
U-MOTION II PS+ CUP (K132455)United Orthopedic Corp.2013-09-03
ARDIS INTERBODY SYSTEM (K131242)Zimmer Spine, Inc.2013-09-03
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, (K123907)Biomet Manufacturing Corp2013-09-03
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE (K131540)Vertebral Technologies, Inc.2013-09-03
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (K132366)Accel Spine2013-09-03
VARILIFT-L INTERBODY FUSION DEVICE (K131296)Wenzel Spine, Inc.2013-09-03
SIRIUS FEMORAL STEM (K130610)Biomet, Inc.2013-08-30
RANGE SPINAL SYSTEM (K131784)K2m, Inc.2013-08-30
UTF STEM-REDUCED, ADDITIONAL SIZES (K132207)United Orthopedic Corporation2013-08-30
ROTATION MEDICAL BONE STAPLE (RMB STAPLE) (K131635)Rotation Medical, Inc.2013-08-29
NUVASIVE DECADE LATERAL PLATE SYSTEM (K130868)Nuvasive, Inc.2013-08-29
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM (K132012)Zimmer Spine, Inc.2013-08-29
ASPIRON ACP SYSTEM (K131200)U&I Corporation2013-08-29
RESTORE BUNION CORRECTION SYSTEM (K131061)Nextremity Solutions2013-08-28
BIORETEC ACTIVASCREW INTERFERENCE (K130716)Bioretec, Ltd.2013-08-28
STALIF X (K130461)Centinel Spine, Inc.2013-08-28
SELF-COMPRESSIVE SCREW (K131471)Neosteo2013-08-28
SEVIIN FRACTURE SHOULDER (K131277)Ingen Orthopedics, LLC2013-08-28
INTERFORM INTERBODY CAGE SYSTEM (K131082)Next Orthosurgical2013-08-26
SEVIIN SURFACE REPLACEMENT SHOULDER (K130635)Ingen Orthopedics, LLC2013-08-26
TEMPUS(TM) CERVICAL PLATE SYSTEM (K131374)Neurostructures, LLC2013-08-23
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM (K131878)Medyssey USA, Inc.2013-08-23
AVENIR CEMENTED HIP STEM (K131884)Zimmer GmbH2013-08-22
FLOWER SMALL AND MEDIUM IMPLANT SET (K131657)Flower Orthopedics Corporation2013-08-22
GMK FULL PE TIBIAL COMPONENTS (K131310)Medacta International2013-08-22
MOUNTAINEER OCT SPINAL SYSTEM (K132332)Medos International SARL2013-08-22
SWING-OFF SCREW (K130627)Advanced Interventional Technology, LLC2013-08-21
STAXX IBL SYSTEM (K131071)Spine Wave, Inc.2013-08-20
CAS PSI SHOULDER (K131129)Zimmer Cas2013-08-20
PAGODA PEDICLE SCREW SYSTEM (K131785)Ortho Development Corp.2013-08-20
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION (K132365)Accel Spine2013-08-20
QUATTRO GL SUTURE ANCHOR (K131325)Cayenne Medical, Inc.2013-08-16
ABG III MONOLITHIC HIP STEM (K123604)Howmedica Osteonics Corp.2013-08-16
ORTHOHELIX STAPLE SYSTEM (K130832)Orthohelix Surgical Designs, Inc.2013-08-15
KINEX BIOACTIVE (K130392)Globus Medical, Inc.2013-08-15
GMK HINGE (K130299)Medacta International2013-08-15
C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K130948)Southern Spine, LLC2013-08-14
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM (K131951)X-Spine Systems, Inc.2013-08-14
HUMELOCK II CEMENTED SHOULDER SYSTEM (K123814)Fx Solutions2013-08-13
VIVORTE BVF LITE (K131133)Vivorte, Inc.2013-08-12
CROSSTREES PVA POD (K130089)Crosstrees Medical, Inc.2013-08-09
ICONACY I-HIP SYSTEM (K131279)Iconacy Orthopedic Implants, LLC2013-08-09
CORE PEDICLE SCREW SYSTEM (K131522)Core-Nexus2013-08-09
METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (K132226)Merete Medical GmbH2013-08-09
SUREFIX INTERSPINOUS FUSION SYSTEM (K124014)Jg Spine, LLC2013-08-09
CAPSURE PS SYSTEM (K132154)Spine Wave, Inc.2013-08-09
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM (K131810)Osseus Fusion Systems, LLC2013-08-08
EXPANDABLE LUMBAR INTERBODY SYSTEM (K130820)Nu Vasive, Incorporated2013-08-08
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM (K131759)Tianjin Walkman Biomaterial Co., Ltd.2013-08-08
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM (K131538)Captiva Spine2013-08-08
FIREBIRD SPINAL FIXATION SYSTEM (K130932)Orthofix, Inc.2013-08-07
I.T.S. EXTREMITY FIXATION SYSTEMS (K131722)I.T.S. GmbH2013-08-07
INTEGRA TITANIUM BONE WEDGE (K131360)Ascension Orthopedic2013-08-07
KATIA SYSTEM (K131512)Shanghai Sanyou Medical Co, Ltd.2013-08-07
CD HORIZON SPINAL SYSTEM (K132111)Medtronic Sofamor Danek USA2013-08-06
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM (K130126)Biomet, Inc.2013-08-06
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM (K122883)Stelkast Company2013-08-05
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 (K123347)Normed Medizin-Technik GmbH2013-08-02
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM (K130814)Depuy Mitek, A Johnson & Johnson Company2013-08-01
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO (K130033)Biomet Manufacturing Corp2013-08-01
COALITION SPACER (K131449)Globus Medical, Inc.2013-07-30
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT (K130302)Spinevision S.A.2013-07-30
MULTIFIX S KNOTLESS FIXATION DEVICE (K131182)Arthocare Corporation2013-07-29
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS (K131264)Gebr. Brasseler GmbH & Co. KG2013-07-26
GMK REVISION EXTENSION (K123721)Medacta International2013-07-26
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS (K130478)Globus Medical, Inc.2013-07-26
JONES-FX FRACTURE SYSTEM (K131620)Instratek, Inc.2013-07-25
HAMMERTOE CORRECTION SYSTEM (K130859)Arthrosurface, Inc.2013-07-25
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) (K131974)Depuy Mitek, A Johnson & Johnson Company2013-07-25
CAPSTONE(R) SPINAL SYSTEM (K123027)Medtronic Sofamor Danek, Inc.2013-07-25
COMPRESSYN BAND (K130431)Dallen Medical, Inc.2013-07-25
REFORM PEDICLE SCREW SYSTEM (K131343)Spinal USA2013-07-24
FRAG-LOC SYSTEM (K130986)Acumed, LLC2013-07-23
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS (K131191)Depuy Mitek, A Johnson & Johnson Company2013-07-22
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW (K130731)Stabiliz Orthopaedics, LLC2013-07-19
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K131467)Conformis, Inc.2013-07-18
LIFE SPINE PLATEAU SPACER SYSTEM (K131077)Life Spine2013-07-17
NEOTIS; NEOTIS 50 (K130953)Sbm Sciences For Bio Materials2013-07-15
611 ANKLE FUSION NAIL (K130051)Tornier S.A.S.2013-07-15
LANX FUSION SYSTEM (K131547)Lanx, Inc.2013-07-12
NEXUS ANTERIOR CERVICAL PLATE SYSTEM (K131520)Core-Nexus2013-07-11
FUSEFORCE IMPLANT SYSTEM (K124045)Solana Surgical, LLC2013-07-10
MECTALIF (K131671)Medacta International2013-07-05
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES (K131283)Wrightmedicaltechnologyinc2013-07-05
TRANSCORP ACIF SYSTEM (K121178)Transcorp, Inc.2013-07-05
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM (K131480)Emerge Medical2013-07-03
DYNASTY ACETABULAR SYSTEM WITH CERAMIC (K130376)Wrightmedicaltechnologyinc2013-07-03
ARTHREX DISTAL RADIUS PLATE SYSTEM (K131474)Arthrex, Inc.2013-07-03
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) (K131670)Biomet, Inc.2013-07-03
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT (K131575)Exactech, Inc.2013-07-03
AFFIX SPINOUS PROCESS PLATE SYSTEM (K131238)Nuvasive, Inc.2013-07-02
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