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510(k) K111940

S 100 PEDICLE SCREW SYSTEM by Renovis Surgical Technologies, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2012
Date Received
July 8, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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  • K143013 — Spinal Inner Fixation System (December 11, 2015)
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