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FDA 510(k) Application Details - K111940
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K111940
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
07/08/2011
Decision Date
05/15/2012
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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