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FDA 510(k) Application Details - K143126
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K143126
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Renovis Surgical Technologies
1901 W. Lugonia Ave., Ste 340
Redlands, CA 92374 US
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Contact
Josh Brown
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
10/31/2014
Decision Date
02/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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