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510(k) K151695

Romeo posterior osteosynthesis system by Spineart — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2015
Date Received
June 23, 2015
Clearance Type
Traditional
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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