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510(k) K150885

MAGEC 2 Spinal Bracing and Distraction System by Ellipse Technologies, Incorporated — Product Code PGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2015
Date Received
April 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.

Other clearances by Ellipse Technologies, Incorporated

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  • K151594 — Ellipse Supplemental Instrument Trays (January 25, 2016)
  • K152370 — PRECICE Trauma Nail System (December 22, 2015)
  • K151131 — PRECICE Intramedullary Limb Lengthening System (June 19, 2015)
  • K150656 — PRECICE Intramedullary Limb Lengthening System (April 23, 2015)
  • K142599 — PRECISE Trauma Nail System (January 16, 2015)

Other clearances for product code PGN

  • K233593 — MAGEC Spinal Bracing and Distraction System (February 6, 2024)
  • K201543 — MAGEC® System (July 30, 2020)
  • K171791 — MAGEC® System (August 31, 2017)
  • K160352 — MAGEC® Spinal Bracing and Distraction System (October 21, 2016)
  • K161751 — MAGEC® Spinal Bracing and Distraction System (September 2, 2016)
  • K141278 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (March 24, 2015)
  • K140613 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (September 18, 2014)
  • K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (February 27, 2014)