ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE MANUFACTURED BY MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL

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Request for Information Form	Contact Information
Company Name	MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL
Address	ROAD 909, KM. 0.4. BARRIO MARIANA
City, State, Zip	HUMACAO, PR 00792
Country	US
FDA Owner/Operator Phone	763-514-4000
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	NVR
FDA Classification Name	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, SOLID-SPHERE, LUMBAR
FDA Device Classification Code
FDA Regulation Number	NULL
FDA Common Generic Name	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE
FDA Proprietary Device Name	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE
FDA Owner / Operator Number	2112641
FDA Owner / Operator Name	MEDTRONIC INC.
FDA Establishment Registration Number	2647346
FDA Registered Establishment Name	MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	03-01-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE
2	MEDTRONIC SOFAMOR DANEK USA, INC. 4340 SWINNEA RD. MEMPHIS, TN 38118 US 763-514-4000 / 901-396-3133 4668	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE
3	WARSAW ORTHOPEDIC, INC. 2500 SILVEUS CROSSING WARSAW, IN 46582 US 763-514-4000 / 901-396-3133 4668	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE