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510(k) K090549

SYNTHES SYNAPSE TRANSCONNECTOR by Synthes Spine — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2009
Date Received
March 2, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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