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FDA 510(k) Application Details - K102026
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K102026
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SEASPINE, INC.
2301 LA MIRADA DR
VISTA, CA 92081 US
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Contact
DAN MILLER
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
07/19/2010
Decision Date
05/12/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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