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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K060692 BIOMET MANUFACTURING CORP. PO BOX 587
WARSAW IN 46581-0587
K193038 Biomet Manufacturing Corp. 56 East Bell Drive
Warsaw IN 46580
K140390 BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE
WARSAW IN 46581-0587
K060716 BIOMET MANUFACTURING CORP. PO BOX 587
WARSAW IN 46581-0587
K123297 BIOMET MANUFACTUTING CORP. 56 EAST BELL DRIVE
WARSAW IN 46581
K112905 BIOMET ORTHOPEDICS LLC. P.O. BOX 587
WARSAW IN 46581-0587
K183553 Biomet, Inc 56 East Bell Drive
Warsaw IN 46581
K032895 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K043100 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K010635 BIOMET, INC. AIRPORT INDUSTRIAL PARK,
WARSAW IN 46581-0587
K130126 BIOMET, INC. 56 EAST BELL DR.
WARSAW IN 46581-0587
K231516 Depuy Ireland UC Loughbeg
Ringaskiddy
K212933 Depuy Ireland UC Loughbeg
Ringaskiddy
K011047 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR.
WARSAW IN 46581-0988
K063652 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K011099 DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE
WARSAW IN 46581-0988
K081448 ENCORE MEDICAL, L.P. 9800 METRIC BLVD.
AUSTIN TX 78758
K162068 Fournitures Hospitalieres Industrie ZI de Kernevez û 6 rue Nobel
Quimper 29000
K202716 Ignite Orthopedics LLC 700 Park Avenue Suite F
Winona Lake IN 46590
K191963 LimaCorporate S.p.A Via Nazionale 52
Villanova di San Daniele del Friuli 33038
K222427 LimaCorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
K201905 LimaCorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
K163397 Limacorporate S.p.A. via Nazionale 52
Villanova di San Daniele 33038
K220792 LimaCorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
K223876 LimaCorporate S.p.A. Via Nazionale 52
Villanova di San Daniele del Friuli 33038
K173824 Shoulder Innovations Inc 13827 Port Sheldon Street
Holland MI 49424
K070565 SMITH & NEPHEW, INC. 1450 E BROOKS RD
MEMPHIS TN 38116
K083439 SYNTHES (USA) 1301 GOSHEN PKWY.
WEST CHESTER PA 19380
K213856 Zimmer Inc. P.O Box 708
Warsaw IN 46581-0708




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact