meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2011-06-13

Clearances · page 79 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102458 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM Solco Biomedical Co., Ltd. MNH Class II 2011-06-13
K110927 MECTALIF Medacta International MAX Class II 2011-06-13
K110933 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. MAX Class II 2011-06-13
K111471 EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) Medshape Solutions, Inc. MBI Class II 2011-06-10
K110070 TSRH SPINAL SYSTEM Medtronic Sofamor Danck USA, Inc. NKB Class II 2011-06-08
K111379 EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT Exactech, Inc. KWS Class II 2011-06-08
K110284 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM Medyssey Co, Ltd. MNI Class II 2011-06-08
K111041 MINI VARIABLE SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2011-06-06
K110773 TORNIER INSITE FT SUTURE ANCHOR Tornier, Inc. MBI Class II 2011-06-02
K110658 APTUS CANNULATED COMPRESSION SCREWS Medartis AG HWC Class II 2011-06-02
K103205 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM Alphatec Spine, Inc. KWP Class II 2011-06-02
K103423 MIS ANTERIOR CERVICAL PLATING SYSTEM Life Spine KWQ Class II 2011-06-01
K111283 GMK REVISION HYBRID LINERS Medacta International JWH Class II 2011-05-27
K110226 INTERFUSE T INVERTEBRAL BODY FUSION DEVICE Vertebral Technologies, Inc. MAX Class II 2011-05-27
K110781 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP Arthrocare Corp. MBI Class II 2011-05-27
K110588 LEUCADIA PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2011-05-25
K110473 NANOTACK SUTURE ANCHOR 1.4MM Pivot Medical MBI Class II 2011-05-25
K110321 TIGER SPINE SYSTEM Corelink, LLC MNH Class II 2011-05-25
K110807 ABG II MONOLITHIC HIP STEM Stryker Corp. MAY Class II 2011-05-25
K110905 TOTAL SHOULDER SYSTEM Shoulder Innovations, LLC KWS Class II 2011-05-24
K111183 ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) Orthofix, Inc. KWP Class II 2011-05-24
K111230 SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW Synthes (USA) Products, LLC HWC Class II 2011-05-24
K110676 TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2011-05-23
K103797 K2M COCR WIRE K2m, Inc. JDQ Class II 2011-05-20
K103382 INTERCONTINENTAL PLATE-SPACER Globus Medical, Inc. OVD Class II 2011-05-20
K110533 STRYKER PATIENT SPECIFIC CUTTING GUIDE Stryker Corp. MBH Class II 2011-05-19
K110230 ROG KNOTLESS SUTURE ANCHOR Rog Sports Medicine, Inc. MBI Class II 2011-05-19
K111039 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM Zimmer, Inc. HRS Class II 2011-05-19
K110283 ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. MNI Class II 2011-05-19
K110229 ROG SUTURE ANCHOR 5.5MM, 2.9MM Rog Sports Medicine, Inc. MBI Class II 2011-05-18
K110574 BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. HRS Class II 2011-05-18
K111001 STERILE STORM (R) OPERATING KIT Intelligent Orthopaedics, Ltd. HWC Class II 2011-05-17
K110706 EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD Exactech, Inc. KWT Class II 2011-05-17
K110415 SIGNATURE PLANNER / SIGNATURE GUIDES Materialise NV HRY Class II 2011-05-16
K110454 COUGAR LS LATERAL CAGE SYSTEM Johnson & Johnson MAX Class II 2011-05-13
K102845 MAHE FIXATION PLATE AND SCREW SYSTEM Mahe Medical GmbH HRS Class II 2011-05-13
K102026 SEASPINE SPACER SYSTEM Seaspine, Inc. MAX Class II 2011-05-12
K110692 STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc. NKB Class II 2011-05-12
K110965 RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM Renovis Surgical Technologies, LLC KTT Class II 2011-05-11
K110399 GLADIATOR PLASMA CLASSIC HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-05-10
K110963 ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM Globus Medical, Inc. KWP Class II 2011-05-05
K103835 REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N Howmedica Osteonics Corp. KWS Class II 2011-05-05
K111099 ISSYS LP SPINAL FIXATION SYSTEM Custom Spine, Inc. NKB Class II 2011-05-05
K094013 HLS KNEETEC SYSTEM Tornier JWH Class II 2011-05-05
K102324 ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM Wrightmedicaltechnologyinc HWC Class II 2011-05-04
K110039 BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM Biomet Sports Medicine JDQ Class II 2011-05-03
K110976 ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM Nanotherapeutics, Inc. MQV Class II 2011-05-03
K110087 CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS Corin USA LZO Class II 2011-05-03
K102843 MAC MALE ADAPTER Biomet Trauma (Aka Ebi, LLC) KTT Class II 2011-05-03
K111056 PICCOLO COMPOSITE NAILING SYSTEM CarboFix Orthopedics , Ltd. HSB Class II 2011-05-03
K110561 FORTROSS BONE VOID FILLER Pioneer Surgical Technology MQV Class II 2011-04-29
K102957 CUTTING EDGE SPINE INTERBODY FUSION DEVICE Cutting Edge Spine, LLC MAX Class II 2011-04-28
K110123 PCL TIGHTROPE Arthrex, Inc. HTY Class II 2011-04-28
K110865 AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM Tornier, Inc. KWS Class II 2011-04-27
K110837 REVISION PROTHESIS Smith & Nephew, Inc. JWH Class II 2011-04-22
K102606 AVS ANCHOR-C CERVICAL CAGE SYSTEM Stryker Spine OVE Class II 2011-04-22
K110125 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM Synthes USA HRS Class II 2011-04-21
K110787 TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) Orthogem Limited MQV Class II 2011-04-21
K110177 HELENA SYSTEM Royal Oak Medical Devices MAX Class II 2011-04-21
K110838 IFUSE IMPLANT SYSTEM SI-BONE, Inc. OUR Class II 2011-04-21
K110029 CONSERVE BIO FOAM SHELL Wrightmedicaltechnologyinc KWA Class III 2011-04-19
K103729 INFILL INTERVERTEBRAL BODY FUSION DEVICE Pinnacle Spine Group, LLC MAX Class II 2011-04-18
K103091 LANX SPINAL FIXATION SYSTEM Lanx, Inc. KWP Class II 2011-04-15
K103662 CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI Zimmer, Inc. LPH Class II 2011-04-15
K093914 NEWDEAL COMPRESSION PLATES Newdeal Sas HRS Class II 2011-04-14
K110547 OPTERTRAK LOGIC PSC TIBIAL INSERT Exactech Sarasota JWH Class II 2011-04-14
K110368 NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC MQV Class II 2011-04-14
K103795 DBX DEMINERALIZED BONE MATRIX PUTTY Musculoskeletal Transplant Foundation MQV Class II 2011-04-13
K103015 ODRC-DYNAMIC HIP SCREW SYSTEM Orthopaedic Device Research Center KTT Class II 2011-04-13
K103784 DBX DEMINERALIZED BONE MATRIX PUTTY Musculoskeletal Transplant Foundation MQV Class II 2011-04-13
K101072 TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE Howmedica Osteonics Corp. LPH Class II 2011-04-11
K110763 LATARJET CORTICAL SCREW SET T.A.G. Medical Products Corporation, Ltd. HWC Class II 2011-04-11
K110101 TAPER OXINIUM FEMORAL HEAD Smith & Nephew, Inc. LZO Class II 2011-04-11
K110067 LP CAGE Medyssey Co, Ltd. MAX Class II 2011-04-08
K110270 ACCULIF CAGE Coalign Innovations, Inc. MAX Class II 2011-04-07
K110353 MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. KWP Class II 2011-04-07
K103262 QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM Tornier, Inc. MBI Class II 2011-04-05
K103369 VAULT ALIF SYSTEM Spinal USA OVD Class II 2011-04-04
K110708 EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... Exactech, Inc. PHX Class II 2011-04-01
K110522 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2011-04-01
K110216 EXPEDIUM SYSTEM, VIPER SYSTEM Depuy Spine, Inc. NKB Class II 2011-04-01
K110542 CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD Consensus Orthopedics, Inc. LPH Class II 2011-04-01
K101484 COMPRESSYN BAND Dallen Medical JDQ Class II 2011-04-01
K110660 ARTHREX BIOCOMPOSITE SUTURETAK Arthrex, Inc. MAI Class II 2011-03-31
K102402 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM Alphatec Spine, Inc. OVD Class II 2011-03-30
K110585 CAPTIVA SPINE FUSELOX CERVICAL CAGE Captiva Spine, Inc. ODP Class II 2011-03-25
K101971 SYNTEC OS SPINAL FIXATION SYSTEM Syntec Scientific Corp. NKB Class II 2011-03-25
K103237 LANX SPINAL SYSTEM Lanx, Inc. NKB Class II 2011-03-25
K102578 APEX PS KNEE SYSTEM Omni Life Science, Inc. JWH Class II 2011-03-25
K103837 BALANCED KNEE SYSTEM REVISION OFFSET TIBIA Ortho Development JWH Class II 2011-03-24
K110555 ARCOMXL ACTIVE ARTICULATION Biomet Manufacturing Corp LPH Class II 2011-03-24
K094035 EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM Stelkast Company OQG Class II 2011-03-24
K103170 GMK REVISION KNEE SC LINERS Medacta International S.A. JWH Class II 2011-03-24
K103111 FORZA SPACER SYSTEM Orthofix, Inc. MAX Class II 2011-03-23
K103666 LANX LATERAL Lanx, Inc. MAX Class II 2011-03-23
K110512 SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. OUR Class II 2011-03-23
K110552 VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW Wrightmedicaltechnologyinc HSB Class II 2011-03-23
K110367 PIONEER SPINAL PROCESS FUSION PLATE Pioneer Surgical Technology, Inc. KWP Class II 2011-03-23
K092138 JTS EXTENDEABLE IMPLANT Stanmore Implants Worldwide , Ltd. KRO Class II 2011-03-22
K103721 MPACT ACETABULAR SYSTEM Medacta International LPH Class II 2011-03-21

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