meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2011-08-19

Clearances · page 78 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111799 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM Ascension Orthopedic HWC Class II 2011-08-19
K110598 SMR REVERSE SHOULDER SYSTEM Lima Corporate S.P.A. PHX Class II 2011-08-18
K111135 PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) K2m, Inc. KWQ Class II 2011-08-17
K111449 REVOLVE ADDITIONAL IMPLANTS Globus Medical, Inc. NKB Class II 2011-08-17
K111479 REVERE CROSSTOP Globus Medical, Inc. NKB Class II 2011-08-17
K111145 ENDO HEAD Medacta International LZY Class II 2011-08-16
K110397 TRUMATCH PERSONALIZED SOLUTIONS DePuy Orthopaedics, Inc. JWH Class II 2011-08-16
K111127 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNI Class II 2011-08-11
K110348 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM Zimmer Spine OWI Class II 2011-08-11
K111437 SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) Synthes (USA) Products, LLC HTO Class I 2011-08-10
K111265 METASURG SUBTALAR IMPLANT Metasurg HWC Class II 2011-08-09
K111044 SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE ArthroCare Corporation MBI Class II 2011-08-09
K110543 CRESCENT (R) SPINAL SYSTEM TITANIUM Medtronic Sofamor Danek USA, Inc. MAX Class II 2011-08-09
K112059 T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP Stryker HSB Class II 2011-08-08
K111590 ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR Rog Sports Medicine, Inc. MBI Class II 2011-08-08
K111779 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 Conmed Linvatec MBI Class II 2011-08-08
K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM Synthes (Usa) HRS Class II 2011-08-08
K100967 PERIMETER C SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. ODP Class II 2011-08-05
K110959 ORTHOPEDIATRICS BLADE PLATE SYSTEM OrthoPediatrics Corp. HRS Class II 2011-08-05
K111478 STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) Stryker Corporation NKB Class II 2011-08-04
K110245 UNITED UTF STEM United Orthopedic Corporation LPH Class II 2011-08-04
K111122 AESCULAP SIBD XP SPINAL SYSTEM Aesculap Implant Systems, Inc. OVD Class II 2011-08-04
K111911 CORIN OPTIMOM MODULAR HEAD Corin USA KWL Class II 2011-08-04
K101934 DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 Medshape Solutions HSB Class II 2011-08-03
K111376 CONSTRUX EXTERNAL FIXATION DEVICE Ebi, LLC KTT Class II 2011-08-03
K110679 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2011-08-02
K110991 MESA SPINAL SYSTEM (KEYSTONE RODS) K2m, Inc. MNI Class II 2011-08-02
K111675 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC ODP Class II 2011-08-02
K103733 UNITED U2 XPE TOTAL KNEE SYSTEM United Orthopedic Corporation JWH Class II 2011-08-02
K110858 LO-BAK TRAX Roland F Berthiaume, DC HST Class I 2011-08-02
K111253 ARTHREX DISTAL EXTREMITY PLATE SYSTEM Arthrex, Inc. HRS Class II 2011-08-02
K111000 PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR Parcus Medical, LLC HWC Class II 2011-07-28
K110789 SYNTHES STERNAL ZIPFIX SYSTEM Synthes (Usa) JDQ Class II 2011-07-28
K111212 SMR SHOULDER SYSTEM- REVISION STEMS Lima Corporate S.P.A. KWS Class II 2011-07-28
K111400 OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT Exactech, Inc. JWH Class II 2011-07-28
K102528 N-FORCE FIXATION SYSTEM Innovision, Inc. HWC Class II 2011-07-28
K110906 APEX SPINE SYSTEM Spinecraft, LLC NKB Class II 2011-07-26
K110990 GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM Gold Standard Orthopedics, LLC KWQ Class II 2011-07-25
K110592 3.7MM/5.0MM DYNAMIC LOCKING SCREW Synthes USA HWC Class II 2011-07-25
K110915 CERVICAL CAGE Eisertech, LLC ODP Class II 2011-07-22
K111631 GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. Depuy Mitek, A Johnson & Johnson Company MBI Class II 2011-07-22
K103414 VENUS CERVICAL SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd. MNI Class II 2011-07-22
K111866 NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2011-07-22
K110271 MAESTRO WRIST PLATING SYSTEM Biomet Manufacturing Corp HRS Class II 2011-07-22
K111536 METASURG DIGIFUSE IMPLANT Metasurg HWC Class II 2011-07-21
K103431 COREN TOTAL HIP SYSTEM Corentec Co., Ltd. LPH Class II 2011-07-21
K103671 GENESYS SPINE TILOCK SYSTEM Genesys Spine NKB Class II 2011-07-21
K111362 REXIOUS SPINAL FIXATION SYSTEM Dio Medical Co., Ltd. MNH Class II 2011-07-21
K100305 ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER Icotec MAX Class II 2011-07-21
K101886 DSC/ALF SPINAL SYSTEM Sintea Plastek, LLC MQP Class II 2011-07-21
K111801 SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. OUR Class II 2011-07-21
K110320 COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM Biomet Manufacturing Corp HRS Class II 2011-07-21
K103831 DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 Depuy Mitek, A Johnson & Johnson Company MAI Class II 2011-07-21
K110201 EXPLOR RADIAL HEAD PLATING SYSTEM Biomet, Inc. HRS Class II 2011-07-21
K111399 SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 Arthrocare Corp. MBI Class II 2011-07-20
K111061 REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) Encore Medical L.P. PHX Class II 2011-07-20
K111774 PATHWAY MODEL 07XXXX Custom Spine MAX Class II 2011-07-20
K102401 HEMI IMPLANT; MINI HEMI IMPLANT Vilex, Inc. KWD Class II 2011-07-20
K111316 AAP CANNULATED SCREWS Aap Implantate AG HWC Class II 2011-07-20
K111469 STAXXSD SYSTEM Spine Wave, Inc. MQP Class II 2011-07-19
K111835 PLATEAU SPACER SYSTEM Life Spine, Inc. ODP Class II 2011-07-19
K103731 CAPSTONE R SPINAL SYSTEM Medtronic Sofamor Danek MAX Class II 2011-07-18
K110847 SMR SHOULDER SYSTEM - CTA HUMERAL HEADS Lima Corporate S.P.A. KWS Class II 2011-07-15
K110197 EXACTECH GIBRALT SPINAL SYSTEM Exactech, Inc. MNI Class II 2011-07-15
K110842 ATLAS SPINE PEDICLE SCREW SYSTEM Atlas Spine, Inc. NKB Class II 2011-07-13
K111062 APEX KNEE SYSTEM, APEX ALL POLY TIBIA Omni Life Science, Inc. JWH Class II 2011-07-13
K110538 PRO FIXATION SYSTEM Synovis Orthopedic & Woundcare HWC Class II 2011-07-12
K111076 SOLANAS AVALON POSTERIOR FIXATION SYSTEM Alphatec Spine, Inc. NKB Class II 2011-07-12
K101997 ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2011-07-12
K110670 VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES Smith & Nephew, Inc. HRS Class II 2011-07-12
K111077 ORTHOSORB RESORBABLE PINS DePuy Orthopaedics, Inc. OVZ Class II 2011-07-12
K111397 TITAN TI SUTURE ANCHOR SYSTEM Arthrocare Corp. MBI Class II 2011-07-12
K111569 PLATEAU SPACER SYSTEM Life Spine MAX Class II 2011-07-06
K110280 REVLOK FENESTRATED SCREW SYSTEM Globus Medical, Inc. NKB Class II 2011-07-06
K111571 VIPER SYSTEMS Johnson & Johnson NKB Class II 2011-07-06
K111326 OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM Graham Medical Technologies, LLC HRS Class II 2011-07-06
K110541 FIGURE 8 STERNOTOMY CLOSURE DEVICE Figure 8 Surgical, Incorporated JDQ Class II 2011-07-06
K111596 TOTAL SHOULDER SYSTEM Shoulder Innovations, LLC KWS Class II 2011-07-05
K110925 NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT Novabone Products, LLC MQV Class II 2011-07-05
K111546 U2 HIP SYSTEM United Orthopedic Corp. LPH Class II 2011-07-01
K111025 TRIGEN LOW PROFILE BONE SCREW Smith & Nephew, Inc. HSB Class II 2011-07-01
K110940 ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN Zimmer, Inc. KRO Class II 2011-07-01
K103655 OCTANE-C INTERBODY FUSION DEVICE SYSTEM Exactech, Inc. ODP Class II 2011-06-30
K110650 ZYSTON ARC INTERBODY SPACER Biomet Spine (Aka Ebi, LLC) MAX Class II 2011-06-30
K111046 CORIN MINIHIP FEMORAL STEM Corin USA LZO Class II 2011-06-29
K103807 IVAS 2-10MM (10 GUAGE) BALLON CATHETER Stryker Corporation NDN Class II 2011-06-28
K110908 APTUS FOOT 3.5 SYSTEM Medartis AG HRS Class II 2011-06-28
K110950 CONSENSUS KNEE SYSTEM Consensus Orthopedics, Inc. MBH Class II 2011-06-27
K111193 APEX ARC HIP STEM Omni Life Science, Inc. LZO Class II 2011-06-27
K110545 SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) Smith & Nephew, Inc. MBI Class II 2011-06-24
K110843 ALEUTIAN SPACER SYSTEM K2m, Inc. MAX Class II 2011-06-22
K111444 UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION DePuy Orthopaedics, Inc. HSB Class II 2011-06-22
K111184 APEX PS KNEE SYSTEM - PS-C INSERT Omni Life Science, Inc. JWH Class II 2011-06-22
K110805 GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) Orthofix, Inc. OBT Class II 2011-06-21
K111410 NUVASIVE LONG LATERAL SPINAL SYSTEM Nuvasive, Inc. KWQ Class II 2011-06-20
K111086 ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM OrthoPediatrics Corp. HRS Class II 2011-06-17
K110947 APEX K1 HIP STEM Omni Life Science, Inc. LPH Class II 2011-06-16
K111564 MAXFIRE MARXMEN MENISCAL REPAIR DEVICE Biomet Sports Medicine MBI Class II 2011-06-16
K110864 BIOSPINE VBR SYSTEM Aesculap Implant Systems, LLC MQP Class II 2011-06-15
K110599 AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM Tornier, Inc. PHX Class II 2011-06-14

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