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510(k) K142114

Xia® Growth Rod Conversion Set by Stryker Corporation — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2014
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Growing Rod System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Stabilization or correction of spinal deformities without the use of fusion.

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