CEMENT, BONE, VERTEBROPLASTY MANUFACTURED BY MEDTRONIC SOFAMOR DANEK USA, INC.

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CEMENT, BONE, VERTEBROPLASTY

Request for Information Form	Contact Information
Company Name	MEDTRONIC SOFAMOR DANEK USA, INC.
Address	4340 SWINNEA RD.
City, State, Zip	MEMPHIS, TN 38118
Country	US
FDA Owner/Operator Phone	763-514-4000
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	NDN
FDA Classification Name	CEMENT, BONE, VERTEBROPLASTY
FDA Device Classification Code	Standards
FDA Regulation Number	888.3027
FDA Common Generic Name	CEMENT, BONE, VERTEBROPLASTY
FDA Proprietary Device Name	CEMENT, BONE, VERTEBROPLASTY
FDA Owner / Operator Number	2112641
FDA Owner / Operator Name	MEDTRONIC INC.
FDA Establishment Registration Number	3003120897
FDA Registered Establishment Name	MEDTRONIC SOFAMOR DANEK USA, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	03-15-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of MEDTRONIC SOFAMOR DANEK USA, INC.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ADVANCED BIOMATERIAL SYSTEMS, INC. 100 PASSAIC AVE. CHATHAM, NJ 07928 US 973-635-9040 / 973-635-9040	CONCERT SPINE VR	BONE CEMENT
2	ARTHROCARE CORP. 680 VAQUEROS AVE. SUNNYVALE, CA 94085 US 408-736-0224 / 408-736-0224	PARALLAX ACRYLIC RESIN WITH TRACERS OR TRACERS TA	PNNA BONE CEMENT
3	CARDINAL HEALTH 400 EAST FOSTER RD. MANNFORD, OK 74044 US 847-689-8410 / 847-578-6610	AVA-TEX	RADIOPAQUE BONE CEMENT
4	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	AVA-TEX	RADIOPAQUE BONE CEMENT
5	DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HAHOSHLIM ST. HERZLIYA, 46724 IS 972-9-9511511 / 972-9-9511511	CONFIDENCE HIGH VISCOSITY BONE CEMENT	STERILE PMMA BONE CEMENT
6	HOWMEDICA INTERNATIONAL S. DE R.L., RAHEEN BUSNIESS PARK LIMERICK, EI 269-385-2600 / 201-831-5002	SPINEPLEX RADIOPAQUE BONE CEMENT	PMMA BONE CEMENT
7	KYPHON, INC. 1221 CROSSMAN AVE. SUNNYVALE, CA 94089 US 408-548-6500 / 408-548-6660	KYPHX HV-R BONE CEMENT	STERILE POLYMETHYLMETHACRYLATE, PMMA, BONE CEMENT
8	STRYKER INTERVENTIONAL PAIN 4664 CAMPUS DR. SUITE 130 KALAMAZOO, MI 49008 US 269-385-2600 / 269-323-7700 3388	SPINEPLEX RADIOPAQUE BONE CEMENT	PMMA BONE CEMENT
9	STRYKER PUERTO RICO, LTD. HWY. 3, KM. 131.2 LAS GUASIMAS IND. PARK ARROYO, PR 00714 US 269-385-2600 / 939-307-2606	SPINEPLEX RADIOPAQUE BONE CEMENT	PMMA BONE CEMENT
10	TECRES SPA VIA ANDREA DORIA 6 SOMMACAMPAGNA VERONA, 37066 IT 390-459-217311 / 390-459-217311	MENDEC SPINE	POLYMETHYLMETHACRYLATE;PMMA;ACRYLIC RESIN FOR VERTEBROPLASTY
11	TEKNIMED SA 11 RUE APOLLO L'UNION, 31240 FR 33-5-62968838 / 512-388-0199	CONFIDENCE BONE CEMENT, VERTEFIX BONE CEMENT	PMMA BONE CEMENT