FDA 510(k) Premarket Notification K963639: ACROMED PEDICLE SCREW

Paragon Medical - Dayton Registration: 1000200989 View Registration

MEDICREA INTERNATIONAL Registration: 1000432246 View Registration

SELENIUM MEDICAL S.A.S. Registration: 1000461041 View Registration

COLIGNE AG Registration: 1000493591 View Registration

Paragon Medical Inc. Registration: 1000517406 View Registration

MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration

ONYX MEDICAL LLC Registration: 1043653 View Registration

MEDTRONIC XOMED, INC. Registration: 1045254 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 View Registration

SOUTHEASTERN TECHNOLOGY dba Autocam Medical Registration: 1057425 View Registration

G-5 FLORIDA LLC Registration: 1066368 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration

SYMMETRY MEDICAL, INC. - MANCHESTER Registration: 1221053 View Registration

ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration

JARVIS SURGICAL INC. Registration: 1223434 View Registration

TOMZ Corporation Registration: 1224360 View Registration

AUTOCAM MEDICAL Registration: 1225838 View Registration

TECOMET Registration: 1226425 View Registration

MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration

Viant AS&O Holdings, LLC Registration: 1319429 View Registration

Sterigenics US LLC Registration: 1423662 View Registration

Isomedix Operations, Inc. Registration: 1424263 View Registration

ARCH Medical Solutions - Elmhurst Registration: 1424434 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

DEPUY SPINE, INC. Registration: 1526439 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC Registration: 1527105 View Registration

Tech Industries. Inc. Registration: 1528646 View Registration

APS MATERIALS, INC. Registration: 1529009 View Registration

HAMMILL MFG. CO. Registration: 1530390 View Registration

TROY INNOVATIVE INSTRUMENTS, INC. Registration: 1530530 View Registration

NORWOOD MEDICAL LLC Registration: 1531174 View Registration

ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration

CENTEX MACHINING, INC. Registration: 1645151 View Registration

BANISTER TOOL, INC. Registration: 1649379 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration

ORTHO DEVELOPMENT CORP. Registration: 1722511 View Registration

ZIMMER, INC. Registration: 1822565 View Registration

WARSAW ORTHOPEDIC, INC. Registration: 1824199 View Registration

FORT WAYNE METALS RESEARCH PRODUCTS, LLC Registration: 1824313 View Registration

BIOMET, INC. Registration: 1825034 View Registration

ORCHID UNIQUE Registration: 1828288 View Registration

SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration

Pioneer Surgical Technology, Inc. Registration: 1833824 View Registration

INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration

PRECISION EDGE SURGICAL PRODUCTS COMPANY Registration: 1833986 View Registration

PARAGON MEDICAL, INC. Registration: 1834331 View Registration

MICROPULSE INC Registration: 1834379 View Registration

NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration

PRECISION MEDICAL TECHNOLOGIES Registration: 1835296 View Registration

Avalign Delivery Systems Division Registration: 1835444 View Registration

MAITLAND ENGINEERING Registration: 1835572 View Registration

Paragon Medical Inc. Registration: 1835831 View Registration

C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration

SURGICAL INSTRUMENT MANUFACTURERS, LLC Registration: 1935627 View Registration

ALPHATEC SPINE, INC. Registration: 2027467 View Registration

EAGLE MEDICAL PACKAGING STERILIZATION, INC. Registration: 2028632 View Registration

Sterigenics U.S., LLC Registration: 2029275 View Registration

JMG MACHINE, INC. Registration: 2031910 View Registration

CLASSIC WIRE CUT COMPANY, INC. Registration: 2031917 View Registration

NUVASIVE, INC. Registration: 2031966 View Registration

HOOSIER, INC. Registration: 2032093 View Registration

Isomedix Operations, Inc Registration: 2032098 View Registration

Isomedix Operations Inc. Registration: 2032112 View Registration

PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration

STOLL METALCRAFT, INC. Registration: 2087234 View Registration

UNITY TOOL, INC. Registration: 2133687 View Registration

Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration

RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration

LOWELL,INC. Registration: 2134470 View Registration

GAUTHIER BIOMEDICAL, INC. Registration: 2134947 View Registration

ORTHOFIX US LLC Registration: 2183449 View Registration

RMS CO. Registration: 2183946 View Registration

Microcision LLC Registration: 2530808 View Registration

The E F PRECISION GROUP Registration: 2531195 View Registration

ARCH - Quakertown Registration: 2531477 View Registration

PULSE TECHNOLOGIES, INC. Registration: 2532027 View Registration

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO Registration: 2647346 View Registration

STERIS ISOMEDIX PUERTO RICO, INC. Registration: 2648623 View Registration

Acero Precision Registration: 3000170817 View Registration

LISI MEDICAL Remmele Registration: 3000203391 View Registration

Synthes GMBH Registration: 3000270450 View Registration

3D MEDICAL MANUFACTURING, INC. (dba Tecomet) Registration: 3001239363 View Registration

MEDTRONIC B.V. (EOC) Registration: 3002807561 View Registration

OURY-GUYE & FILS Registration: 3002976036 View Registration

MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration

Phillips Precision Inc Registration: 3003387384 View Registration

QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration

ALDEN TOOL COMPANY, INC. Registration: 3003525643 View Registration

SPINEVISION SAS Registration: 3003526896 View Registration

T & L SHARPENING, INC. Registration: 3003541440 View Registration

OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration

HARWOOD DESIGN, INC. Registration: 3003761012 View Registration

MACKAY MANUFACTURING, INC. Registration: 3003935342 View Registration

STRYKER SPINE Registration: 3004024955 View Registration

GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration

DONSON MACHINE COMPANY Registration: 3004153896 View Registration

B & G MFG. CO. Registration: 3004188066 View Registration

DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration

LIFE SPINE Registration: 3004499989 View Registration

C&W SWISS, INC. Registration: 3004635447 View Registration

PURACON GMBH Registration: 3004638532 View Registration

SPINECRAFT LLC Registration: 3004717358 View Registration

INNOVASIS, INC. Registration: 3004719693 View Registration

SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration

K2M, INC. Registration: 3004774118 View Registration

LDR MEDICAL Registration: 3004788213 View Registration

SPINAL ELEMENTS, INC. Registration: 3004893332 View Registration

Alpha AI Co., Ltd. Registration: 3004941535 View Registration

Xtant Medical Holdings, Inc. Registration: 3005031160 View Registration

SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration

PROCON MEDIZINTECHNIK GMBH Registration: 3005076207 View Registration

MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration

Tecomet, Inc. Registration: 3005226664 View Registration

ELITE SURGICAL SUPPLIES (PTY) LTD Registration: 3005325790 View Registration

Paradigm Spine GmbH Registration: 3005426761 View Registration

MICRO PRECISION SWISS Registration: 3005497913 View Registration

BGS Beta-Gamma-Service GmbH & Co KG Registration: 3005562917 View Registration

GS MEDICAL CO., LTD. Registration: 3005596514 View Registration

PACIFIC INSTRUMENTS INC. Registration: 3005641619 View Registration

Medtronic (Changzhou) Medical Devices Technology Co., Ltd Registration: 3005677016 View Registration

TURNER MEDICAL INC. Registration: 3005706667 View Registration

Precision Spine, Inc. Registration: 3005739886 View Registration

Choice Spine LLC Registration: 3005819474 View Registration

ULRICH MEDICAL USA, INC. Registration: 3005823819 View Registration

ARCH-MedTorque Registration: 3005874553 View Registration

BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration

SOUTHERN SPINE, LLC Registration: 3006110997 View Registration

Nemcomed FW LLC Registration: 3006128100 View Registration

Wenzel Spine Registration: 3006172536 View Registration

Unified Spine, LLC Registration: 3006215390 View Registration

COULOT DECOLLETAGE Registration: 3006217744 View Registration

HG Medical GmbH Registration: 3006272282 View Registration

JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Registration: 3006356043 View Registration

G SURGICAL CO., LTD. Registration: 3006378738 View Registration

ORTHOPEDIATRICS, CORP Registration: 3006460162 View Registration

CEFIMECA Registration: 3006563559 View Registration

SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD Registration: 3006639944 View Registration

STRUCTURE MEDICAL, LLC. Registration: 3006783837 View Registration

ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS Registration: 3006791286 View Registration

Bradshaw Medical Inc. Registration: 3006846753 View Registration

Remington Medical, Inc. Registration: 3007014520 View Registration

Apex (Guangzhou) Tools & Orthopedics Company Registration: 3007125392 View Registration

LINCOTEK TRENTO S.P.A Registration: 3007353762 View Registration

MOSER-BAER AG Registration: 3007441485 View Registration

MEDYSSEY CO., LTD. Registration: 3007485169 View Registration

Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration

HC BIOLOGICS LLC Registration: 3007604895 View Registration

IMPLANET Registration: 3007675554 View Registration

SPINEART SA Registration: 3007728266 View Registration

ProCon Implants GmbH Registration: 3007766698 View Registration

PAONAN BIOTECH CO., LTD Registration: 3007887127 View Registration

NEXXT SPINE LLC Registration: 3007922509 View Registration

Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration

Structure Medical, LLC. Registration: 3007993775 View Registration

MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

ROBERT REID INC. Registration: 3008198024 View Registration

L&K BIOMED CO.,LTD. Registration: 3008285983 View Registration

GENESYS SPINE Registration: 3008455034 View Registration

Organ Eco Tech Registration: 3008526708 View Registration

SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration

ZAVATION Registration: 3008583793 View Registration

Synthes (USA) Products LLC Registration: 3008812560 View Registration

GS Solutions, Inc. Registration: 3008850074 View Registration

EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration

CLARIANCE-SAS Registration: 3008992889 View Registration

ALTUS PARTNERS Registration: 3009049161 View Registration

INSERT MOLDING SOLUTIONS, INC. Registration: 3009050824 View Registration

CTL Medical Corporation Registration: 3009051471 View Registration

NUVASIVE, INC. Registration: 3009144915 View Registration

A.F.T. MICROMECANIQUE Registration: 3009149199 View Registration

G Surgical LLC Registration: 3009169872 View Registration

NUTECH SPINE, INC. Registration: 3009169996 View Registration

CARAGH PRECISION Registration: 3009173317 View Registration

Eurofins STERIPAC GMBH Registration: 3009217531 View Registration

Medtronic Distribution Center Registration: 3009380063 View Registration

SYNTHES GMBH Registration: 3009417901 View Registration

Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration

SAFE ORTHOPAEDICS SAS Registration: 3009509485 View Registration

Medartis Inc. Registration: 3009540749 View Registration

CG MedTech USA, Inc. Registration: 3009554293 View Registration

RED STAR CONTRACT MANUFACTURING INC. Registration: 3009631939 View Registration

SPINAL SIMPLICITY, LLC Registration: 3009704301 View Registration

BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration

UOC USA Inc. Registration: 3009760038 View Registration

AEGIS MEDITEC, INC. Registration: 3009790163 View Registration

Elite Medical, LLC Registration: 3009882675 View Registration

Complexus Medical Registration: 3009887475 View Registration

Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration

LISI MEDICAL REmmele Registration: 3009941480 View Registration

Ferry Machine Corporation Registration: 3009959868 View Registration

ARCH Medical Solutions - Warsaw Registration: 3009971621 View Registration

Engineered Medical Systems, LLC Registration: 3009973336 View Registration

ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration

B & J Medical LLC Registration: 3009973699 View Registration

Mendell Registration: 3009998573 View Registration

rms Surgical Registration: 3010009693 View Registration

FIRST ARTICLE INC Registration: 3010032903 View Registration

J&B PRECISION, INC. Registration: 3010041430 View Registration

Tegra Medical Registration: 3010041499 View Registration

PRECISION FORMS, INC. Registration: 3010041993 View Registration

CULVER TOOL & ENGINEERING Registration: 3010047454 View Registration

JATEX, INC. Registration: 3010049501 View Registration

LH MEDICAL CORPORATION Registration: 3010057495 View Registration

Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration

BRANCH MEDICAL GROUP Registration: 3010120104 View Registration

FLEX-CELL PRECISION, INC. Registration: 3010120135 View Registration

J & J Precision Technologies, LLC Registration: 3010120148 View Registration

WESTWOOD PRECISION LLC Registration: 3010120339 View Registration

ARCH Medical Solutions - Olive Branch Registration: 3010123206 View Registration

MEDTECH LLC Registration: 3010123256 View Registration

AR FABRICATING Registration: 3010143171 View Registration

Synergy Health Allershausen GmbH Registration: 3010160527 View Registration

Synergy Health Marseille SAS Registration: 3010162973 View Registration

IONISOS Registration: 3010178296 View Registration

AMERICAN MANUFACTURING AND ENGINEERING Registration: 3010197224 View Registration

Synergy Sterilisation South Africa Proprietary Ltd Registration: 3010287685 View Registration

Microtec SAS Registration: 3010365473 View Registration

FMI MEDISCH BV Registration: 3010370500 View Registration

Euclide Care Registration: 3010370554 View Registration

SIMON SAS Registration: 3010370880 View Registration

Double Medical Technology Inc. Registration: 3010440433 View Registration

SIMAGEC Registration: 3010462278 View Registration

MIKRON MAKINA SANAYI VE TICARET LTD. STI. Registration: 3010646402 View Registration

DEGEN MEDICAL Registration: 3010663372 View Registration

Pantheon Spinal LLC Registration: 3010665091 View Registration

AXIAL MEDICAL Registration: 3010863450 View Registration

ACUITY SURGICAL DEVICES, LLC Registration: 3010866843 View Registration

INCIPIO DEVICES Registration: 3011015572 View Registration

SURGTECH, INC. Registration: 3011170410 View Registration

XENCO MEDICAL LLC Registration: 3011181154 View Registration

INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT Registration: 3011187779 View Registration

LOPITZ MANUFACTURING Registration: 3011221483 View Registration

CEP BIO-COAT, LLC Registration: 3011277306 View Registration

FLOSPINE LLC Registration: 3011513267 View Registration

Titan Spine, a Division of Medtronic Registration: 3011577940 View Registration

MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH Registration: 3011795235 View Registration

REPUBLIC SPINE Registration: 3011796723 View Registration

MEDICAL COMPONENT SPECIALISTS Registration: 3011874600 View Registration

SEASPINE ORTHOPEDICS CORPORATION Registration: 3012120772 View Registration

CURITEVA, INC. Registration: 3012131184 View Registration

UNITED ORTHOPEDIC CORPORATION Registration: 3012329926 View Registration

XENIX MEDICAL Registration: 3012429289 View Registration

Highridge Medical, LLC Registration: 3012447612 View Registration

Summit Orthopedic Technologies Inc. Registration: 3012491394 View Registration

SURGENTEC LLC Registration: 3012495575 View Registration

DECOMICRO SAS Registration: 3012599928 View Registration

ZIBO DANTE CO, LTD Registration: 3012711663 View Registration

Silony Medical International AG Registration: 3012764194 View Registration

MAHE MEDICAL USA Registration: 3013011598 View Registration

Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration

EUROFINS INPAC MEDIZINTECHNIK GMBH Registration: 3013111980 View Registration

SILONY MEDICAL GMBH Registration: 3013422236 View Registration

Silony Spine Corporation Registration: 3013422238 View Registration

NML Medical, LLC Registration: 3013491327 View Registration

BAUI BIOTECH CO., LTD. Registration: 3013514648 View Registration

Safe Medical Registration: 3013548554 View Registration

C&A Tool Engineering, Inc. Auburn Plant Registration: 3014252644 View Registration

INGENIUMSPINE, LLC Registration: 3014268622 View Registration

PRECISION MEDICAL TECHNOLOGIES Registration: 3014273424 View Registration

Tangible Solutions, Inc. DBA Marle Tangible, Inc. Registration: 3014273501 View Registration

ABLE MEDICAL DEVICES Registration: 3014680795 View Registration

Medtronic Medical Costa Rica S.R.L. Registration: 3014725904 View Registration

INDIUS MEDICAL TECHNOLOGIES PVT. LTD. Registration: 3014938863 View Registration

Precision Medical Technologies- North Manchester Manufacturing Facility Registration: 3015179588 View Registration

Jabil Inc. (Brandywine) Registration: 3015212339 View Registration

S.M.A.I.O Registration: 3015383864 View Registration

Kyocera Medical Technologies, Inc. Registration: 3015398319 View Registration

Jabil Inc. (Monument) Registration: 3015399803 View Registration

Jabil Inc. (Elmira) Registration: 3015440604 View Registration

Jabil Switzerland Manufacturing GmbH (Le Locle) Registration: 3015831087 View Registration

Jabil Switzerland Manufacturing GmbH (Raron) Registration: 3015869121 View Registration

Jabil Switzerland Manufacturing GmbH (Mezzovico) Registration: 3015869493 View Registration

Jabil Switzerland Manufacturing GmbH (Hagendorf) Registration: 3015876273 View Registration

Astura Medical Registration: 3015941638 View Registration

Olive Branch Distribution Center Registration: 3016050940 View Registration

MOUNT MFG Registration: 3016084569 View Registration

GUARDIAN MEDICAL USA, INC Registration: 3016261131 View Registration

ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED Registration: 3016443334 View Registration

TESLAKE, INC. Registration: 3016496998 View Registration

ARTFX MEDICAL LLC Registration: 3017435639 View Registration

Elite Medical, LLC Registration: 3017528621 View Registration

Elite Medical, LLC Registration: 3017565094 View Registration

Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration

BRANCH MEDICAL GROUP Registration: 3019767615 View Registration

VY SPINE, LLC Registration: 3019837678 View Registration

Alphatec Spine, Inc. Registration: 3019878714 View Registration

APS Materials Suzhou Registration: 3020282716 View Registration

INFIGO MEDICAL Registration: 3022159082 View Registration

OSTEOMED IMPLANTES Registration: 3023138345 View Registration

PHEN'X TECHNOLOGIES Registration: 3023265483 View Registration

Hipp Medical AG Registration: 3023852420 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration

BOXSPINE, LLC Registration: 3027807601 View Registration

GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration

MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration

DePuy Synthes Sales Registration: 3034676720 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration

ALPES CN SAS Registration: 3037407500 View Registration

OSTEOMNI INC Registration: 3041915189 View Registration

FERRY MACHINE CORPORATION Registration: 3043543260 View Registration

BIEDERMANN MOTECH GMBH & Co. KG Registration: 8010944 View Registration

ANTHOGYR Registration: 8020776 View Registration

STERIS Schweiz AG Registration: 8043792 View Registration

AESCULAP AG Registration: 9610612 View Registration

FRIEDRICH DANIELS GMBH Registration: 9611390 View Registration

ILG MEDIZINTECHNIK GMBH Registration: 9611610 View Registration

CHRISTIAN DIENER GMBH Registration: 9611813 View Registration

ERCHINGER AG Registration: 9611827 View Registration

JAKUTEC MEDIZINTECHNIK GMBH & Co. KG Registration: 9612277 View Registration

ULRICH GMBH & CO. KG Registration: 9612420 View Registration

Corin Limited Registration: 9614209 View Registration

SIGNUS MEDIZINTECHNIK GMBH Registration: 9615021 View Registration

Cousin Biotech Registration: 9616062 View Registration

CG MedTech Co., Ltd. Registration: 9617297 View Registration

STRYKER SPINE Registration: 9617544 View Registration

Gammatom S.r.l. Registration: 9681465 View Registration

UNITED ORTHOPEDIC CORP. Registration: 9681642 View Registration

ACROMED PEDICLE SCREW

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