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510(k) K102853

FLAMENCO SPINAL FIXATION SYSTEM by Ulrich GmbH & Co. KG — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2011
Date Received
September 29, 2010
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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