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510(k) K140750

SHILLA GROWTH GUIDANCE SYSTEM by Medtronic Sofamor Danek USA, Inc. — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2014
Date Received
March 25, 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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  • K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen (September 24, 2019)
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  • K180227 — Polaris Spinal Growth System (March 15, 2018)
  • K172979 — NuVasive® Growth Rod Conversion Set (November 6, 2017)
  • K161028 — K2M Growing Spine System (July 22, 2016)
  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)