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

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

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K010869	ARGOMEDICAL AG	800 VINAL STREET, STE B-210	PITTSBURGH	PA	15212
K042321	BIOMET MANUFACTURING CORP.	56 EAST BELL DRIVE	WARSAW	IN	46581-0587
K223631	Biomet Orthopedics	56 East Bell Drive	Warsaw	IN	46581
K020045	BIOMET ORTHOPEDICS, INC.	P.O. BOX 587	WARSAW	IN	46581-0587
K023063	BIOMET ORTHOPEDICS, INC.	P.O. BOX 587	WARSAW	IN	46581-0587
K030710	BIOMET, INC.	56 BELL DR.	WARSAW	IN	46581-0587
K002998	BIOMET, INC.	AIRPORT INDUSTRIAL PARK,	WARSAW	IN	46581-0587
K991585	BIOMET, INC.	AIRPORT INDUSTRIAL PARK,	WARSAW	IN	46581-0587
K961571	BIOMET, INC.	AIRPORT INDUSTRIAL PARK,	WARSAW	IN	46581-0587
K111746	BIOMET, INC.	56 EAST BELL DR.	WARSAW	IN	46581-0587
K043505	BIOMET, INC.	56 EAST BELL DR.	WARSAW	IN	46581-0587
K032507	BIOMET, INC.	56 BELL DR.	WARSAW	IN	46581-0587
K022079	BIOMET, INC.	P.O. BOX 587	WARSAW	IN	46581-0587
K152825	CATALYST ORTHOSCIENCE LLC	5867 WHISPERWOOD CT	NAPLES	FL	34110
K173812	Catalyst OrthoScience, Inc	14710 Tamiami Trail North, Suite 102	Naples	FL	34110
K182500	Catalyst OrthoScience, Inc.	14710 Tamiami Trail North	Naples	FL	34110
K181287	Catalyst OrthoScience, Inc.	14710 Tamiami Trail North, Suite 102	Naples	FL	34110
K191811	Catalyst OrthoScience, Inc.	14710 Tamiami Trail North, Suite 102	Naples	FL	34110
K984541	DEPUY ORTHOPAEDICS, INC.	700 ORTHOPAEDIC DRIVE	WARSAW	IN	46581-0988
K991603	ENCORE ORTHOPEDICS, INC.	9800 METRIC BLVD.	AUSTIN	TX	78758
K960424	ENDOTEC, INC.	111 ORANGE ST.	BLOOMFIELD	NJ	07003
K162903	Exactech Inc	2320 NW 66th Court	Gainesville	FL	32653
K143659	EXACTECH, INC.	2320 Northwest 66th Court	Gainesville	FL	32653
K110706	EXACTECH, INC.	2320 N.W. 66TH CT.	GAINESVILLE	FL	32653
K191698	FX Shoulder USA, Inc.	13465 Midway Road, Suite 101	Dallas	TX	75244
K123814	FX SOLUTIONS	1663 RUE DE MAJORNAS	VIRIAT		01440
K140071	FX SOLUTIONS	1663 RUE DE MAJORNAS	VIRIAT		01440
K222482	implantcast, GmbH	Luneburger Schanze 26	Buxtehude		21615
K241944	implantcast, GmbH	Lⁿneburger Schanze 26	Buxtehude		21614
K231657	Implantcast, GmbH	Luneburger Schanze 26	Buxtehude		21614
K022377	IMPLEX CORP.	80 COMMERCE DR.	ALLENDALE	NJ	07401-1600
K962315	INTERMEDICS ORTHOPEDICS	9900 SPECTRUM DR.	AUSTIN	TX	78717
K970567	INTERMEDICS ORTHOPEDICS	9900 SPECTRUM DR.	AUSTIN	TX	78717
K962238	INTERMEDICS ORTHOPEDICS	9900 SPECTRUM DR.	AUSTIN	TX	78717
K962244	INTERMEDICS ORTHOPEDICS	9900 SPECTRUM DR.	AUSTIN	TX	78717
K100858	LIMA-LTO S.P.A.	PO BOX 696	WINONA LAKE	IN	46590
K101263	LIMA-LTO S.P.A.	PO BOX 696	WINONA LAKE	IN	46590
K161476	Limacorporate S.p.A.	Via Nazionale, 52	Udine		33038
K071147	NEXA ORTHOPEDICS, INC.	49 PLAIN ST.	NORTH ATTLEBORO	MA	02760
K190595	Orthosoft Inc. (d/b/a Zimmer CAS)	75 Queen Street	Montreal		h3c 2n6
K192365	Shoulder Innovations Inc	13827 Port Sheldon Street	Holland	MI	49424
K241817	Shoulder Innovations, Inc.	1535 Steele Ave SW, Suite B	Grand Rapids	MI	49507
K014049	STELKAST COMPANY	800 VINIAL ST. #210	PITTSBURGH	PA	15212
K210899	Waldemar Link GmbH & Co. KG	Oststrasse 4-10	Norderstedt		22844
K150730	ZIMMER	75, QUEEN STREET, SUITE 3300	MONTREAL		H3C 2N6
K103404	ZIMMER GMBH	P.O. BOX 708	WARSAW	IN	46581-0708
K110791	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708
K982981	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708
K041549	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708
K050761	ZIMMER, INC.	345 E. MAIN ST.	WARSAW	IN	46580
K121543	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708