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510(k) K141509

ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS by Medos Sarl — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2014
Date Received
June 6, 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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