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510(k) K102488

APEX SPINE SYSTEM W/ COCR RODS by Spinecraft, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
August 31, 2010
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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