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FDA 510(k) Application Details - K121116
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K121116
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
LIFE SPINE
2401 Hassell Rd Ste 1535
Hoffman Est, IL 60169 US
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Contact
RANDY LEWIS
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
04/12/2012
Decision Date
05/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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