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

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

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K060670	ACCIN CORPORATION	1033 US HIGHWAY 46 EAST	CLIFTON	NJ	07013
K063782	ACCIN CORPORATION	1033 US HIGHWAY 46 EAST	CLIFTON	NJ	07013
K101206	ALEXANDRIA RESEARCH TECHNOLOGIES, LLC	13755 FIRST AVENUE NORTH	PLYMOUTH	MN	55441
K090024	ALEXANDRIA RESEARCH TECHNOLOGIES, LLC	13755 FIRST AVENUE NORTH	PLYMOUTH	MN	55441
K251453	Arthrex Inc.	1370 Creeksidew Blvd.	Naples	FL	34108
K200433	Arthrex Inc.	1370 Creekside Boulevard	Naples	FL	34108
K161060	Arthrex, Inc.	1370 Creekside Boulevard	Naples	FL	34108-1945
K050373	ARTHROSURFACE, INC.	28 FORGE PARKWAY	FRANKLIN	MA	02038
K161592	BIOMET, INC.	56 EAST BELL DR.	WARSAW	IN	46581
K123380	BLUE BELT TECHNOLOGIES, INC.	2828 LIBERTY AVENUE	PITTSBURGH	PA	15222
K181302	Bodycad Laboratories Inc.	2035, rue du Haut-Bord	Quebec City		G1N 4R7
K203697	Bodycad Laboratories, Inc.		Quebec City		G1N 4R7
K191996	Bodycad Laboratories, Inc.	2035, rue du Haut-Bord	Quebec City		g1n 4r7
K211895	Bodycad Laboratories, Inc.	2035, rue du Haut-Bord	Quebec City		G1N 4R7
K212307	Bodycad Laboratories, Inc.	2035, rue du Haut-Bord	Quebec City		G1N 4R7
K163700	Bodycad Laboratories, Inc.	2035, rue du Haut-Bord	Quebec City		g1n 4r7
K191150	Bodycad Laboratories, Inc.	2035, rue du Haut-Bord	Quebec City		g1n 4r7
K111916	CONFORMIS, INC.	11 NORTH AVENUE	BURLINGTON	MA	01803
K121974	CONFORMIS, INC.	11 NORTH AVENUE	BURLINGTON	MA	01803
K072368	CONFORMIS, INC.	2 FOURTH AVENUE	BURLINGTON	MA	01803
K063432	CONFORMIS, INC.	323-C VINTAGE PARK DR.	FOSTER CITY	CA	94404
K072586	CONFORMIS, INC.	2 FOURTH AVENUE	BURLINGTON	MA	01803
K132640	CONFORMIS, INC.	28 Crosby Dr	Bedford	MA	01730
K092441	CONFORMIS, INC.	2 FOURTH AVENUE	BURLINGTON	MA	01803
K043570	CONFORMIS, INC.	323 VINTAGE PARK DR.	FOSTER CITY	CA	94404
K170344	Consensus Orthopedics, Inc	1115 Windfield Way	El Dorado Hills	CA	95762
K191325	Encore Medical, L.P.	9800 Metric Blvd.	Austin	TX	78758
K241260	Globus Medical, Inc	Valley Forge Business Center	Audubon	PA	19403
K033769	HOWMEDICA OSTEONICS CORP	325 CORPORATE DR.	MAHWAH	NJ	07430
K203099	Howmedica Osteonics Corp aka Stryker Orthopaedics	325 Corporate Dr.	Mahwah	NJ	07430
K180612	Howmedica Osteonics Corp aka Stryker Orthopaedics	325 Corporate Dr.	Mahwah	NJ	07430
K992287	HOWMEDICA OSTEONICS CORP.	59 ROUTE 17 SOUTH	ALLENDALE	NJ	07401-1677
K203341	Implantcast GmbH	Lueneburger Schanze 26	Buxtehude		21614
K232114	Kyocera Medical Technologies Inc.	1200 California Street	Redlands	CA	92374
K954186	LINK AMERICA, INC.	C/O SURGICAL IMPLANTS, INC.	EAST HANAVOR	NJ	07936
K080368	MAKO SURGICAL CORP.	2555 DAVIE RD., SUITE 110	FT. LAUDERDALE	FL	33317
K082081	MAKO SURGICAL CORP.	2555 DAVIE RD.	FORT LAUDERDALE	FL	33317
K060017	MAKO SURGICAL CORP.	2901 SIMMS STREET	HOLLYWOOD	FL	33020
K073248	MAKO SURGICAL CORP.	2555 DAVIE RD., SUITE 110	FT. LAUDERDALE	FL	33317
K220930	Mako Surgical Corp.	3365 Enterprise Ave	Weston	FL	33331
K082172	MAKO SURGICAL CORPORATION	2555 DAVIE ROAD	FORT LAUDERDALE	FL	33317
K112301	MATERIALISE N.V.	15 TECHNOLOGIELAAN	LEUVEN		3001
K172650	Materialise NV	Technologielaan 15	Leuven		3001
K173970	Materialise NV	Technologielaan 15	Leuven		3001
K202207	Materialise NV	Technologielaan 15	Leuven		3001
K251618	Medacta International S.A.	Strada Regina	Castel San Pietro		6874
K213071	Medacta International S.A.	Strada Regina	Castel San Pietro		CH-6874
K161741	MEDACTA INTERNATIONAL SA	STRADA REGINA	Castel San Pietro		CH-6874
K162084	Medacta International SA	Strada Regina	Castel San Pietro		CH-6874
K183029	Medacta International SA	Strada Regina	Castel San Pietro		CH-6874
K211471	Ortho Development Corporation	12187 South Business Park Drive	Draper	UT	84020
K242746	Overture Orthopaedics	5 Peters Canyon Road	Irvine	CA	92606
K221292	Overture Resurfacing Inc.	1617 3rd Ave, #287284	New York	NY	10128
K212870	Signature Orthopaedics Pty Ltd.	7 Sirius Road	Lane Cove		2066
K190085	Smith & Nephew Inc	7135 Goodlett Farms Parkway	Cordova	TN	38016
K061779	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K061011	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K100197	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K152315	Smith & Nephew, Inc.	7135 Goodlett Farms Parkway	Cordova	TN	38016
K191211	Smith & Nephew, Inc.	7135 Goodlett Farms Parkway	Cordova	TN	38016
K242711	Smith & Nephew, Inc.	1450 Brooks Rd	Memphis	TN	38116
K073175	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K102069	SMITH & NEPHEW, INC.	1450 BROOKS ROAD	MEMPHIS	TN	38116
K081351	SMITH & NEPHEW, INC.	1450 E BROOKS ROAD	MEMPHIS	TN	38116
K113038	SMITH & NEPHEW, INC.	1450 BROOKS RD.	MEMPHIS	TN	38116
K211512	Smith & Nephew, Inc.	7135 Goodlett Farms Parkway	Cordova	TN	38016
K160738	SMITH & NEPHEW, INC.	7135 GOODLETT FARMS PARKWAY	CORDOVA	TN	38016
K032824	STELKAST COMPANY	200 HIDDEN VALLEY ROAD	MCMURRAY	PA	15317
K011954	SULZER ORTHOPEDICS, INC.	9900 SPECTRUM DR.	AUSTIN	TX	78717
K022211	TORNIER	ZIRST-161, RUE LAVOISIER	MONTBONNOT		38330
K120262	TORNIER, INC.	161, RUE LAVOISIER	MONTBONNOT		38334
K010685	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708
K200151	Zimmer, Inc.	1800 W. Center Street	Warsaw	IN	46580
K033363	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708
K122529	ZIMMER, INC.	P.O. BOX 708	WARSAW	IN	46581-0708