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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 K062992
Device Name SPINAL SPHERES
Applicant
Interbody Innovations, Llp
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J D WEBB
Correspondent
Interbody Innovations, Llp
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J D WEBB
Classification Product Code
NVR  
Date Received10/02/2006
Decision Date 07/27/2007
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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