FDA 510(k) Applications for Medical Device:
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K081293 AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY.
CENTER VALLEY PA 18034
K131167 AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway
Center Valley PA 18034
K060412 AUSTRALIAN SURGICAL DESIGN & MANUFACTURE 2530 RIVA ROAD, SUITE 308
ANNAPOLIS MD 21401
K122277 BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE
WARSAW IN 46581-0587
K061681 BIOMET MANUFACTURING CORP. PO BOX 587
WARSAW IN 46581-0587
K053299 BIOMET MANUFACTURING, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K063515 BIOMET MANUFACTURING, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K020264 BIOMET ORTHOPEDICS, INC. P.O. BOX 587
WARSAW IN 46581-0587
K133940 BIOMET UK LTD. 56 EAST BELL DRIVE
WARSAW IN 46581
K011509 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K021621 BIOMET, INC. P.O. BOX 587
WARSAW IN 46581-0587
K011138 BIOMET, INC. P.O. BOX 587
WARSAW IN 46581-0587
K971938 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K980665 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K030446 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K042093 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K011795 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K033810 CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR.
AUSTIN TX 78717
K050764 CORIN U.S.A. 10500 UNIVERSITY CENTER DR.,
TAMPA FL 33612
K193549 DePuy Ireland UC Loughbeg
Ringaskiddy
K000172 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K070267 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46582
K010810 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46581-0988
K040268 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K001451 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K022437 ENCORE MEDICAL, L.P. 9800 METRIC BLVD.
AUSTIN TX 78758
K020741 ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD.
AUSTIN TX 78758
K040889 EXACTECH, INC. 2320 N.W. 66TH CT.
GAINESVILLE FL 32653
K033351 GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT
OVIEDO FL 32765
K051721 GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT
OVIEDO FL 32765-5018
K082567 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K071881 HOWMEDICA OSTEONICS CORP 325 CORPORATE DR.
MAHWAH NJ 07430
K955778 INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR.
AUSTIN TX 78717
K954481 JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N.
RARITAN NJ 08869
K150410 MAKO SURGICAL CORPORATION 2555 DAVIE ROAD
FORT LAUDERDALE FL 33317
K110415 MATERIALISE N.V. 15 TECHNOLOGIELAAN
LEUVEN 3001
K152631 MICROPORT ORTHOPEDICS, INC. 5677 AIRLINE ROAD
ARLINGTON TN 38002
K190633 NanoOrtho, LLC 860 Oak Park Blvd STE 301
Arroyo Grande CA 93420
K012762 OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD.
HUNT VALLEY MD 21031-1201
K983657 OSTEONICS CORP. 59 ROUTE 17
ALLENDALE NJ 07401-1677
K974434 OSTEONICS CORP. 59 ROUTE 17
ALLENDALE NJ 07401-1677
K032052 PLUS ORTHOPEDICS 1001 OAKWOOD BLVD.
ROUND ROCK TX 78681-2700
K982859 PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT.
SAN DIEGO CA 92121-1122
K072704 VALPO ORTHOPEDIC TECHNOLOGY, INC. 438 E 200 N
WARSAW IN 46582
K012800 WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD.
ST. LOUIS MO 63141
K030193 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K960617 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K012591 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K014171 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K100973 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002
K961900 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002




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