FDA 510(k) Application Details - K073274

Device Classification Name Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

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510(K) Number K073274
Device Name Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Applicant LIFE SPINE
2401 W. HASSELL RD.
SUITE 1535
HOFFMAN ESTATES, IL 60169 US
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Contact REBECCA M BROOKS
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Regulation Number 000.0000

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Classification Product Code NVR
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Date Received 11/21/2007
Decision Date 03/17/2008
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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