INFUSE BONE GRAFT MANUFACTURED BY MEDTRONIC SOFAMOR DANEK USA, INC.

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INFUSE BONE GRAFT

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	SU - General Plastic Surgery
FDA Product Code	LMF
FDA Classification Name	AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	878.4490
FDA Common Generic Name	COLLAGEN SPONGE
FDA Proprietary Device Name	INFUSE BONE GRAFT
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)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	02-12-02
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	BAXTER HEALTHCARE CORPORATION 21026 ALEXANDER COURT HAYWARD, CA 94545 US 805-372-3040 / 847-473-6141	MULTIPLE	STERILE HEMOSTATIC SEALANT KIT
2	BAXTER HEALTHCARE CORPORATION, MEDICATION DELIVERY 17511 ARMSTRONG AVE. IRVINE, CA 92614 US 847-948-2000 / 847-473-6141	MULTIPLE	STERILE HEMOSTATIC SEALANT KIT
3	DAVOL INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD CRANSTON, RI 02920 US 908-277-8000 / 908-277-8513	AVITENE	MICROFIBRILLER COLLAGEN HEMOSTAT(MCH) FLOUR MICROFIBRILLAR NON-WOVEN
4	ETHICON, INC. 655 ETHICON CIR. CORNELIA, GA 30531 US 908-218-2887 / 908-218-2996	MULTIPLE	STERILE ABSORBABLE HEMOSTATIC AGENT (BOVINE COLLAGEN)
5	ETHICON, INC. ROUTE 22 WEST SOMERVILLE, NJ 08876 US 908-218-2887 / 908-218-2996	MULTIPLE	STERILE ABSORBABLE HEMOSTATIC, COLLAGEN BASED
6	ETHICON, LLC. RD. 183, KM. 8.3, INDUSTRIAL AREA HATO SAN LORENZO, PR 00754 US 908-218-2887 / 908-218-2996	MULTIPLE	STERILE ABSORBABLE HEMOSTATIC, COLLAGEN BASED
7	INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE PLAINSBORO, NJ 08536 US 609-275-0500 / 609-936-2311	MULTIPLE	VARIOUS
8	INTERVENTIONAL PRODUCTS DIVISION 1300 MACARTHUR BLVD. MAHWAH, NJ 07430 US 201-391-8100 / 201-995-8758	FIRST STOP	COLLAGEN HEMOSTAT, VARIOUS SIZES AND STYLES
9	MEDCHEM PRODUCTS, INC. 160 NEW BOSTON ST. WOBURN, MA 01801 US 908-277-8000 / 908-277-8513	AVITENE	MICROFIBRILLER COLLAGEN HEMOSTAT(MCH) FLOUR MICROFIBRILLAR NON-WOVEN
10	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	INFUSE BONE GRAFT	COLLAGEN SPONGE
11	ORTHOVITA, INC. 45 GREAT VALLEY PKWY. MALVERN, PA 19355 US 610-640-1775 / 610-407-5246	VITAGEL SURGICAL HEMOSTAT	STERILE SURGICAL HEMOSTAT
12	XEMAX SURGICAL PRODUCTS, INC. 712 CALIFORNIA BLVD. NAPA, CA 94559 US 800-257-9470 / 800-257-9470	COLLASTAT OBP	MICROFIBRILLAR ABSORBABLE COLLAGEN HEMOSTAT