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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K021661 BIOMET ORTHOPEDICS, INC. P.O. BOX 587
WARSAW IN 46581-0587
K030047 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K021728 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K030923 CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR.
AUSTIN TX 78717
K071059 DEPUY ORTHOPAEDICS, INC. P.O. BOX 988
WARSAW IN 46581-0988
K071117 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46582
K052079 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K043058 DEPUY, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46582
K023794 ENCORE MEDICAL, L.P. 9800 METRIC BLVD.
AUSTIN TX 78758
K161610 Encore Medical, L.P. 9800 METIRC BLVD
AUSTIN TX 78758
K163497 ENCORE MEDICAL, L.P. 9800 METRIC BLVD.
Austin TX 78758
K040601 EXACTECH, INC. 2320 N.W. 66TH CT.
GAINESVILLE FL 32653
K071676 EXACTECH, INC. 2320 N.W. 66TH CT.
GAINESVILLE FL 32653
K063445 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K063552 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K063550 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K061654 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K040225 OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD.
HUNT VALLEY MD 21031-1201
K083566 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K021803 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K033442 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K122139 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K111635 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K162641 Smith & Nephew, Inc. 7135 Goodlett Farms Parkway
Cordova TN 38016
K101730 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708
K072121 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708
K021826 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708
K071718 ZIMMER, INC. P.O. BOX 708
WARSAW IN 46581-0708




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