meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2010-05-27

Clearances · page 84 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100857 FUSION MEDICAL RING LOCK SYSTEM John J Riccio KTT Class II 2010-05-27
K093405 PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc MBH Class II 2010-05-25
K092528 BIOMET FORERUNNER LOCKING PLATE SYSTEM Biomet Trauma (Aka Ebi, Lp) HRS Class II 2010-05-21
K090861 MAMBO, MODEL CS 18XX-XX Ulrich GmbH & Co. KG KWQ Class II 2010-05-21
K092695 TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM Transcorp, Inc. KWQ Class II 2010-05-21
K101175 KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER Kfx Medical MBI Class II 2010-05-20
K093820 SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 Memometal Technologies HWC Class II 2010-05-19
K101151 REGENT ANTERIOR CERVICAL PLATE Custom Spine KWQ Class II 2010-05-19
K083798 IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF Medicrea Technologies MAX Class II 2010-05-19
K100008 CARDO MEDICAL CERAMIC HIP SYSTEM Cardo Medical, Inc. LZO Class II 2010-05-18
K101184 TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 Arthrocare Corp. MBI Class II 2010-05-18
K100240 ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM OrthoPediatrics Corp. HRS Class II 2010-05-17
K100220 POLARIS SPINAL SYSTEM Ebi, L.P. NKB Class II 2010-05-17
K100271 VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES Howmedica Osteonics Corp. HRS Class II 2010-05-14
K100788 COCR RODS Globus Medical, Inc. NKB Class II 2010-05-14
K100089 SYNTHES T-PAL SPACER Synthes Spine MAX Class II 2010-05-13
K101056 VARIAX ELBOW SYSTEM Howmedica Osteonics Corp. HRS Class II 2010-05-13
K100265 DIAMOND ANTERIOR CERVICAL PLATE SYSTEM Amendia, Inc. KWQ Class II 2010-05-13
K100897 LEGION POROUS + HA TIBIAL BASEPLATES Smith & Nephew, Inc. MBH Class II 2010-05-13
K092190 SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS Synthes (Usa) KTT Class II 2010-05-11
K092812 SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES Synthes (Usa) HRS Class II 2010-05-11
K100238 HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc. HSB Class II 2010-05-11
K093978 EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM Exactech, Inc. HRS Class II 2010-05-11
K094002 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM Spartek Medical, Inc. NKB Class II 2010-05-07
K100142 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier PHX Class II 2010-05-06
K100412 BIOLOX DELTA CERAMIC FEMORAL HEADS Smith & Nephew, Inc. LZO Class II 2010-05-05
K100325 PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES Smith & Nephew, Inc. HWC Class II 2010-05-04
K100614 HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES Blackstone Medical, Inc. KWQ Class II 2010-05-04
K093235 RINGLOC + HYBRID ACETABULAR SYSTEM Biomet, Inc. KWA Class III 2010-04-30
K100475 AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS Howmedica Osteonics Corp. HRS Class II 2010-04-30
K100012 GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A Depuy Mitek, A Johnson & Johnson Company MAI Class II 2010-04-30
K091797 TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2010-04-30
K093561 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc. LPH Class II 2010-04-28
K092901 EPICAGE INTERBODY FUSION DEVICE R Tree Innovations MAX Class II 2010-04-28
K100410 PIEZOELECTRIC SYSTEM Satelec JDX Class II 2010-04-28
K093770 EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC HWC Class II 2010-04-28
K100866 PROFEMUR HIP SYSTEM MODULAR NECKS Wrightmedicaltechnologyinc LZO Class II 2010-04-28
K092748 SURESHOT TAN NAILS AND ACCESSORIES Smith & Nephew, Inc. HSB Class II 2010-04-26
K094025 CRESCENT SPINAL SYSTEM Medtronic Sofamor Danek MAX Class II 2010-04-26
K093207 ENDURAMESH, MODEL 762.XXX Lucero Medical, LLC MQP Class II 2010-04-26
K100377 DIAMONDBACK SPINAL SYSTEM Eminent Spine MNI Class II 2010-04-22
K094045 MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM Cardo Medical Corp. LPH Class II 2010-04-22
K100361 NANOSS BONE VOID FILLER Pioneer Surgical Technology MQV Class II 2010-04-22
K093343 GRAFTY QUICKSET Graftys MQV Class II 2010-04-22
K090982 SMITH & NEPHEW HIP SYSTEMS WITH HA Smith & Nephew, Inc. MEH Class II 2010-04-21
K100618 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY Orthohelix Surgical Designs, Inc. HRS Class II 2010-04-20
K100312 DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM Dgimed Ortho, Inc. HSB Class II 2010-04-20
K100159 SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. MBI Class II 2010-04-19
K093880 PEANUT GROWTH CONTROL PLATING SYSTEM Ebi, L.P. HRS Class II 2010-04-16
K093991 SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS Smith & Nephew, Inc. LZO Class II 2010-04-15
K092198 CORMET CEMENTLESS RESURFACING FEMORAL HEAD Corin USA KXA Class II 2010-04-15
K100191 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) Lanx, Inc. KWP Class II 2010-04-15
K093746 VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2010-04-14
K092521 ZUMA-C Seaspine, Inc. OVE Class II 2010-04-13
K100737 MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM Stryker Spine NKB Class II 2010-04-12
K100111 NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc. HRS Class II 2010-04-12
K090975 DEROYAL NON-LOCKING BONE FIXATION SYSTEM Deroyal Industries, Inc. HRS Class II 2010-04-12
K093806 MYKNEE CUTTING BLOCKS Medacta International S.A. JWH Class II 2010-04-08
K100676 SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL Synthes (Usa) HRS Class II 2010-04-08
K100215 ARCHIMED REMEDY CERVICAL PLATE Archimed, Inc. KWQ Class II 2010-04-07
K092765 LANX ANTERIOR PLATING SYSTEM Lanx, Inc. KWQ Class II 2010-04-07
K090845 APEX ARC HIP STEM Omni Life Science, Inc. LZO Class II 2010-04-07
K083312 MINIHIP STEM Corin USA LZO Class II 2010-04-05
K093935 SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR Smith & Nephew, Inc. MBI Class II 2010-04-05
K092076 AEGIS & AEGIS II SPINAL SYSTEM Corentec Co., Ltd. MNI Class II 2010-04-02
K091955 STRYKER SONICPIN SYSTEM Howmedica Osteonics Corp. HTY Class II 2010-04-02
K093844 SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR Smith & Nephew, Inc. MAI Class II 2010-04-01
K100575 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM Ldr Spine USA MNI Class II 2010-03-31
K100555 APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK Omni Life Science, Inc. LPH Class II 2010-03-29
K093772 SYNTHES STERNAL FIXATION SYSTEM Synthes HRS Class II 2010-03-29
K093928 SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES Synthes (Usa) HRS Class II 2010-03-29
K092493 GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM Gpc Medical, Ltd. HRS Class II 2010-03-29
K093776 INDUS ANTERIOR CERVICAL PLATE SYSTEM Spinefrontier, Inc. KWQ Class II 2010-03-26
K100579 G-FORCE TI SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 2010-03-26
K093808 INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE Incite Innovation, LLC OVD Class II 2010-03-24
K092046 BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY Berkeley Advanced Biomaterials, Inc. MQV Class II 2010-03-24
K100457 OPUS SPEEDSCREW SYSTEM Arthrocare Corp. HWC Class II 2010-03-19
K093983 SMPLE PLATE AND SCREWS Biomet Trauma (Aka Ebi, Lp) HRS Class II 2010-03-19
K093669 SEC IBF CAGE Innvotec Surgical, Inc. MAX Class II 2010-03-18
K093419 IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS Stryker Instruments, Instruments Div. NDN Class II 2010-03-18
K093912 ARTHREX TIBIAL GRAFTBOLT Arthrex, Inc. MBI Class II 2010-03-18
K093670 MODIFICATION TO: OASYS SYSTEM Stryker Spine MNH Class II 2010-03-18
K093676 OMNITECH LARGE, TRIMED COMPRESSION SCREW TriMed, Inc. HWC Class II 2010-03-17
K100532 VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 Depuy Mitek, A Johnson & Johnson Company HWC Class II 2010-03-17
K100484 IMPIX MANTA CERVICAL INTERBODY DEVICE Medicrea ODP Class II 2010-03-16
K092825 APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER Spinecraft, Inc. KWP Class II 2010-03-16
K092265 VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS Medacta International S.A. MEH Class II 2010-03-12
K093936 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNI Class II 2010-03-11
K092474 PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2m, Inc. KWQ Class II 2010-03-11
K093864 AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX Stryker Corp. MAX Class II 2010-03-11
K094037 TC PLATING SYSTEM Ortho-Pro, LLC HRS Class II 2010-03-10
K093629 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM Biomet Spine OVD Class II 2010-03-09
K100048 E1 ANTIOXIDANT INFUSED TECHNOLOGY Biomet Manufacturing Corp OIY Class II 2010-03-09
K093668 SYNTHES MATRIX MIS RODS Synthes (Usa) NKB Class II 2010-03-09
K094017 TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 Omni Life Science, Inc. JWH Class II 2010-03-05
K093943 BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM Smith & Nephew Inc., Endoscopy Div. MBI Class II 2010-03-05
K093677 STRYKER ARTHROSCOPE Stryker Endoscopy HRX Class II 2010-03-05
K092211 CHESAPEAKE SPINAL SYSTEM K2m, Inc. OVD Class II 2010-03-05
K093761 OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM Biomet Trauma (Aka Ebi, Lp) HRS Class II 2010-03-05
K083186 AESCULAP HYDROLIFT VBR SYSTEM Aesculap Implant System, Inc. MQP Class II 2010-03-04

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