OREGON SPINE SPLINT II MANUFACTURED BY SKEDCO, INC.

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Request for Information Form	Contact Information
Company Name	SKEDCO, INC.
Address	10505 SW MANHASSET DR. P.O. BOX 3390
City, State, Zip	TUALATIN, OR 97062
Country	US
FDA Owner/Operator Phone	503-691-7909
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	MAT
FDA Classification Name	ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY
FDA Device Classification Code
FDA Regulation Number	NULL
FDA Common Generic Name	OSS, OSS II
FDA Proprietary Device Name	OREGON SPINE SPLINT II
FDA Owner / Operator Number	9000211
FDA Owner / Operator Name	SKEDCO, INC.
FDA Establishment Registration Number	3025123
FDA Registered Establishment Name	SKEDCO, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-10-97
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	DEPUY SPINE, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3769 / 508-828-3769	ACROPLATE ANTERIOR CERVICAL PLATING SYSTEM	CERVICAL ANTERIOR PLATE
2	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	ORION ANTERIOR CERVICAL PLATE SYSTEM	CERVICAL IMPLANT FIXATION DEVICE
3	WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668	ORION ANTERIOR CERVICAL PLATE SYSTEM	CERVICAL IMPLANT FIXATION DEVICE
4	ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US 800-613-6131 / 952-830-6273	CERVI-LOK SPINAL FIXATION SYSTEM	SPINAL FIXATION PLATES AND SCREWS