SPINAL CONCEPTS, INC. PATHFINDER MANUFACTURED BY ABBOTT SPINE, INC.

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SPINAL CONCEPTS, INC. PATHFINDER

Request for Information Form	Contact Information
Company Name	ABBOTT SPINE, INC.
Address	12708 RIATA VISTA CIRCLE SUITE B-100
City, State, Zip	AUSTIN, TX 78727
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	NKB
FDA Classification Name	ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	888.3070
FDA Common Generic Name	PEDICLE SCREW SYSTEM
FDA Proprietary Device Name	SPINAL CONCEPTS, INC. PATHFINDER
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	1649384
FDA Registered Establishment Name	ABBOTT SPINE, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-12-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ABBOTT SPINE, 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	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	S4 SPINAL OCCIPUT PLATE SYSTEM	PEDICLE SCREW SYSTEM
2	AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US 610-984-9074 / 610-984-9074	S4 SPINAL OCCIPUT PLATE SYSTEM	PEDICLE SCREW SPINAL SYSTEM
3	AESCULAP IMPLANT SYSTEMS 615 LAMBERT POINTE DRIVE HAZELWOOD, MO 63042 US 610-984-9074 / 610-984-9074	S4 SPINAL OCCIPUT PLATE SYSTEM	PEDICLE SCREW SPINAL SYSTEM
4	ALLEZ SPINE, LLC 2301 DUPONT DRIVE, SUITE 510 IRVINE, CA 92612 US 619-885-7733 / 619-885-7733	ALLEZ SPINE PEDICLE SCREW SYSTEM	SPINAL FIXATION SYSTEM
5	CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 PARSIPPANY, NJ 07054 US 973-808-0019 / 973-808-0019	ISSYS LP FIXATION SYSTEM	PEDICLE SCREW SPINAL SYSTEM
6	EBI, L.P. 100 INTERPACE PKWY. PARSIPPANY, NJ 07054 US 973-299-9300 / 973-299-9300 3964	ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II	SPINAL FIXATION SYSTEM
7	ENDIUS, INC. 23 WEST BACON ST. PLAINVILLE, MA 02762 US 800-613-6131 / 508-643-0983 114	SPINAL FIXATION SYSTEM, MULTIPLE	PEDICLE SCREW SYSTEM
8	GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER AUDUBON, PA 19403 US 610-415-9000 / 610-415-9000 1680	REVERE STABILIZATION SYSTEM	STABILIZATION SYSTEM
9	LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 HOFFMAN ESTATES, IL 60169 US 847-884-6117 / 847-884-6117	ARX-LINK CROSS CONNECTOR	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
10	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM	METALLIC BONE FIXATION DEVICE
11	MEDTRONIC SOFAMOR DANEK USA, INC. 4340 SWINNEA RD. MEMPHIS, TN 38118 US 763-514-4000 / 901-396-3133 4668	TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM	METALLIC BONE FIXATION DEVICE
12	SEASPINE, INC. 2302 LA MIRADA DR. VISTA, CA 92081 US 760-727-8399 209 / 760-727-8399 218	UCR,MALIBU	COMPLETE PEDICLE SCREW SPINAL SYSTEM
13	STRYKER SPINE ZONE INDUSTRIELLE DEMARTICOT CESTAS, AQUITAINE, 33610 FR 269-385-2600 / 335-579-70840	MULTIPLE	SPINAL FIXATION APPLIANCES
14	STRYKER SPINE 2 PEARL COURT ALLENDALE, NJ 07401 US 269-385-2600 / 201-760-8150	MULTIPLE	SPINAL FIXATION APPLIANCES
15	STRYKER SPINE SA LE CRET DU LOCLE 10A LA CHAUX DE FONDS, 2300 SZ 269-385-2600 / 33-357-970840	MULTIPLE	VARIOUS SPINAL FIXATION DEVICES
16	SYNTHES BETTLACH GMBH MURACHERSTRASSE 3 BETTLACH, SO, 2544 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES OF SPINAL FIXATION DEVICES
17	SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF SPINAL PEDICLE FIXATION ORTHOSES FOR DEGENERATIVE DI
18	SYNTHES HAGENDORF GMBH IM BIFANG HAGENDORF, CH-4614 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF SPINAL PEDICLE FIXATION ORTHOSES FOR DEGENERATIVE DI
19	SYNTHES MEZZOVICO GMBH ZONA INDUSTRIALE 4 MEZZOVICO, CH-6805 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF DEGENERATIVE DISC DISEASE SPINAL PEDICLE FIXATION ORT
20	ULRICH GMBH & CO. KG BUCHBRUNNENWEG 12 ULM, D-89081 GM 07-31-9654-0 / 004-973-19654x163	TANGORS POLYAXIAL SYSTEM	SPINAL IMPLANT SYSTEM
21	VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 CARLSBAD, CA 92008 US 760-448-4800 233 / 760-448-4800 233	VERTIFLEX SPINAL SCREW SYSTEM	PEDICLE SCREW SYSTEM
22	WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668	TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM	METALLIC BONE FIXATION DEVICE
23	ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US 800-613-6131 / 952-830-6273	ST 360 SPINAL FIXATION SYSTEM	PEDICLE SCREW SYSTEM