FDA 510(k) Applications for Medical Device: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA 510(k) Applications for Medical Device:
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K992525	ACUMED, INC.	10950 S.W. 5TH ST.	BEAVERTON	OR	97005
K233260	Arthrex Inc.	1370 Creekside Boulevard	Naples	FL	34108-1945
K221232	Arthrex Inc.	1370 Creekside Boulevard	Naples	FL	34108-1945
K130675	ARTHREX, INC.	1370 CREEKSIDE BLVD.	NAPLES	FL	34108-1945
K151527	ARTHREX, INC.	1370 CREEKSIDE BOULEVARD	NAPLES	FL	34108-1945
K161782	ARTHREX, INC.	1370 CREEKSIDE BLVD.	NAPLES	FL	34108-1945
K142942	ARTHROSURFACE INC.	28 FORGE PARKWAY	FRANKLIN	MA	02038
K173964	Arthrosurface, Inc.	28 Forge Parkway	Franklin	MA	02038
K071064	ASCENSION ORTHOPEDICS, INC.	8700 CAMERON RD., STE. 100	AUSTIN	TX	78754-3832
K062861	ASCENSION ORTHOPEDICS, INC.	8700 CAMERON RD., STE. 100	AUSTIN	TX	78754-3832
K061862	AXIOM ORTHOPAEDICS, INC.	49 PLAIN STREET	NORTH ATTLEBORO	MA	02760
K193122	Biocore9, LLC.	9 Whippany Road, Bldg A1, Unit 12	Whippany	NJ	07981
K010657	BIOMET MANUFACTURING, INC.	AIRPORT INDUSTRIAL PARK	WARSAW	IN	46581-0587
K010664	BIOMET MANUFACTURING, INC.	AIRPORT INDUSTRIAL PARK	WARSAW	IN	46581-0587
K010827	BIOMET ORTHOPEDICS, INC.	P.O. BOX 587	WARSAW	IN	46581-0587
K051843	BIOMET, INC.	56 EAST BELL DR.	WARSAW	IN	46581-0587
K003044	BIOMET, INC.	AIRPORT INDUSTRIAL PARK,	WARSAW	IN	46581-0587
K003428	BIOMET, INC.	AIRPORT INDUSTRIAL PARK,	WARSAW	IN	46581-0587
K961260	BIOMET, INC.	AIRPORT INDUSTRIAL PARK	WARSAW	IN	46581
K012377	CORIN U.S.A.	10500 UNIVERSITY CENTER DR.,	TAMPA	FL	33612
K082715	DEPUY ORTHOPAEDICS, INC.	700 ORTHOPAEDIC DRIVE	WARSAW	IN	46581-0988
K080990	DEPUY ORTHOPAEDICS, INC.	700 ORTHOPAEDIC DRIVE	WARSAW	IN	46581-0988
K033516	DEPUY ORTHOPAEDICS, INC.	700 ORTHOPAEDIC DR.	WARSAW	IN	46581-0988
K031971	DEPUY ORTHOPAEDICS, INC.	700 ORTHOPAEDIC DR.	WARSAW	IN	46581-0988
K073331	DVO EXTREMITY SOLUTIONS, LLC	720 E WINONA AVE	WARSAW	IN	46580
K992394	ENDOTEC, INC.	20 VALLEY ST.	SOUTH ORANGE	NJ	07079
K131298	EXACTECH, INC.	2320 N.W. 66TH CT.	GAINESVILLE	FL	32653
K061454	EXACTECH, INC.	2320 N.W. 66TH CT.	GAINESVILLE	FL	32653
K111097	FX SOLUTIONS	1663 RUE DE MAJORNAS	VIRIAT		01440
K130759	FX SOLUTIONS	1663 RUE DE MAJORNAS	VIRIAT		01440
K954559	HOWMEDICA CORP.	359 VETERANS BLVD.	RUTHERFORD	NJ	07070
K040128	HOWMEDICA OSTEONICS CORP	325 CORPORATE DR.	MAHWAH	NJ	07430
K070963	HOWMEDICA OSTEONICS CORP	325 CORPORATE DR.	MAHWAH	NJ	07430
K061677	HOWMEDICA OSTEONICS CORP	325 CORPORATE DR.	MAHWAH	NJ	07430
K062845	HOWMEDICA OSTEONICS CORP.	325 Corporate Drive	Mahwah	NJ	07430
K032264	HOWMEDICA OSTEONICS CORP.	59 ROUTE 17 SOUTH	ALLENDALE	NJ	07401-1677
K001419	HOWMEDICA OSTEONICS CORP.	59 ROUTE 17 SOUTH	ALLENDALE	NJ	07401-1677
K984202	HOWMEDICA, INC.	359 VETERANS BLVD.	RUTHERFORD	NJ	07070
K191433	Implantcast GmbH	Lueneburger Schanze 26	Buxtehude		21614
K130635	INGEN ORTHOPEDICS LLC	2650 US HIGHWAY 130	CRANBURY	NJ	08512
K962289	INTERMEDICS ORTHOPEDICS	9900 SPECTRUM DR.	AUSTIN	TX	78717
K112900	LIMACORPORATE S.P.A.	P.O. BOX 696	WINONA LAKE	IN	46590-696
K982886	OSTEOIMPLANT TECHNOLOGY, INC.	11201 PEPPER RD.	HUNT VALLEY	MD	21031-1201
K032126	PLUS ORTHOPEDICS	1001 OAKWOOD BLVD.	ROUND ROCK	TX	78681-2700
K063578	PLUS ORTHOPEDICS AG	18 BRIDIE LANE	NORFOLK	MA	02056
K121714	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K023096	STD MFG., INC.	1063 TURNPIKE ST.	STOUGHTON	MA	02072
K040432	STRYKER ORTHOPAEDICS	325 Corporate Drive	Mahwah	NJ	07430
K072578	SYNTHES (USA)	1302 WRIGHTS LANE EAST	WEST CHESTER	PA	19380
K112983	TECRES SPA	7 Trail House Court	Rockville	MD	20850
K060535	TECRES SPA	2320 N.W. 66TH COURT	GAINSVILLE	FL	32653
K011942	TORNIER	RUE DOYEN GOSSE	ST. ISMIER		38330
K062661	TORNIER	161 RUE LAVOISIER	MONTBONNOT, SAINT-ISMIER		38334
K063081	TORNIER	161 RUE LAVOISIER	MONTBONNOT, SAINT-ISMIER		38334
K161620	ZIMMER GMBH	SULZERALLEE 8	WINTERTHUR		8404