FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K082146 AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY.
CENTER VALLEY PA 18034
K061699 AESCULAP, INC. 3773 Corporate Parkway
Center Valley PA 18034
K042344 AESCULAP, INC. 3773 Corporate Parkway
Center Valley PA 18034
K962268 ARTOS MEDICAL PRODUCTS GMBH CASTLEWAY DRIVE WEST,SUITE 236
INDIANAPOLIS IN 46250
K962034 ARTOS MEDICAL PRODUCTS GMBH CASTLEWAY DRIVE WEST,SUITE 236
INDIANAPOLIS IN 46250
K120595 CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100
EL DORADO HILLS CA 95762
K010243 CORIN U.S.A. 10500 UNIVERSITY CENTER DR.,
TAMPA FL 33612
K103518 CORIN U.S.A. 10500 UNIVERSITY CENTER DR.,
TAMPA FL 33612
K030122 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K002941 ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD.
AUSTIN TX 78758
K960633 ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD.,
AUSTIN TX 78757
K964178 ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD.,
AUSTIN TX 78757
K002141 EXACTECH, INC. 2320 N.W. 66TH CT.
GAINESVILLE FL 32653
K090764 EXACTECH, INC. 2320 N.W. 66TH CT.
GAINESVILLE FL 32653
K070061 HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100
EL DORADO HILLS CA 95762-9623
K003649 HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100
EL DORADO HILLS CA 95762-9623
K062383 HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100
EL DORADO HILLS CA 95762-9623
K972931 HHL CONSULTING 835 CORTEZ LN.
FOSTER CITY CA 94404
K023692 HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH
ALLENDALE NJ 07401-1677
K993601 HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD.
RUTHERFORD NJ 07070-2584
K022966 IMPLEX CORP. 80 COMMERCE DR.
ALLENDALE NJ 07401-1600
K001471 IMPLEX CORP. 80 COMMERCE DR.
ALLENDALE NJ 07401-1600
K954854 INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR.
AUSTIN TX 78717
K963155 INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR.
AUSTIN TX 78717
K040685 OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD.
HUNT VALLEY MD 21031-1201
K982936 OSTEONICS CORP. 59 ROUTE 17
ALLENDALE NJ 07401-1677
K994146 PLUS ORTHOPEDICS 200 GREGORY LN.
PLEASANT HILL CA 94553-3389
K030971 PLUS ORTHOPEDICS 1001 OAKWOOD BLVD.
ROUND ROCK TX 78681-2700
K032709 PLUS ORTHOPEDICS 1001 OAKWOOD BLVD.
ROUND ROCK TX 78681-2700
K994126 PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT.
SAN DIEGO CA 92121-1194
K973077 PLUS ORTHOPEDICS 835 CORTEZ LN.
FOREST CITY CA 94404
K001942 PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT.
SAN DIEGO CA 92121-1122
K024134 PLUS ORTHOPEDICS 1001 OAKWOOD BLVD.
ROUND ROCK TX 78681-2700
K971900 PRO-LFIC LLC. 500 WEST PUTNAM AVE., 3RD FLR.
GREENWICH CT 06830
K953268 STELKAST COMPANY 800 VINIAL ST. #210
PITTSBURGH PA 15212
K001745 STELKAST COMPANY 800 VINIAL ST. #210
PITTSBURGH PA 15212
K002796 STELKAST COMPANY 800 VINIAL ST. #210
PITTSBURGH PA 15212
K032110 STELKAST COMPANY 200 HIDDEN VALLEY RD.
MCMURRAY PA 15317
K960908 STELKAST COMPANY 800 VINIAL ST. #210
PITTSBURGH PA 15212
K002575 SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR.
AUSTIN TX 78717
K050262 UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK
HSINCHU 300
K062978 UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK
HSINCHU 300
K051826 WALDEMAR LINK GMBH & CO. KG 1835 MARKET STREET
PHILADELPHIA PA 19103
K033313 WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD.
ST. LOUIS MO 63141
K955553 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K003016 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K961378 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708
K952776 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708




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