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510(k) K201543

MAGEC® System by Nuvasive Specialized Orthopedics, Inc. — Product Code PGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2020
Date Received
June 9, 2020
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 Nuvasive Specialized Orthopedics, Inc.

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  • K200430 — Precice® Ankle Salvage System (September 16, 2020)
  • K201567 — Precice® Bone Transport System (August 10, 2020)
  • K193617 — Precice® Screws (May 8, 2020)
  • K193016 — PRECICE Bone Transport System (May 8, 2020)
  • K192181 — PRECICE Plating System (November 7, 2019)
  • K191336 — PRECICE System (September 26, 2019)
  • K182170 — PRECICE® BONE TRANSPORT™ System (February 5, 2019)

Other clearances for product code PGN

  • K233593 — MAGEC Spinal Bracing and Distraction System (February 6, 2024)
  • 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)
  • K150885 — MAGEC 2 Spinal Bracing and Distraction System (May 29, 2015)
  • 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)