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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
510(k) Number K073274
Device Name SPINAL SPHERE SYSTEM
Applicant
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Applicant Contact REBECCA M BROOKS
Correspondent
Life Spine
2401 W. Hassell Rd.
Suite 1535
Hoffman Estates,  IL  60169
Correspondent Contact REBECCA M BROOKS
Classification Product Code
NVR  
Date Received11/21/2007
Decision Date 03/17/2008
Decision SE - With Limitations (SESU)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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