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510(k) K061577

OVALTWIST PEDICLE SCREW SYSTEM by Signus Medizintechnik GmbH — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2006
Date Received
June 7, 2006
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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