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510(k) K161751

MAGEC® Spinal Bracing and Distraction System by Nuvasive Specialized Orthopedics, Inc. — Product Code PGN

K161751 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Inc. for the device "MAGEC® Spinal Bracing and Distraction System". The FDA issued a decision of Substantially Equivalent on September 2, 2016. The device falls under product code PGN (Growing Rod System- Magnetic Actuation), a Class II device regulated under 21 CFR 888.3070. Nuvasive Specialized Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2016
Date Received
June 24, 2016
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.

  • K261651 — Precice™ Max System and Precice™ Ankle Salvage System (June 18, 2026)
  • K230765 — Precice Ankle Salvage System (August 29, 2023)
  • K220234 — Precice Intramedullary Limb Lengthening System (March 15, 2023)
  • K202348 — External Remote Controller ERC 4P (December 22, 2020)
  • K200430 — Precice® Ankle Salvage System (September 16, 2020)
  • K201567 — Precice® Bone Transport System (August 10, 2020)
  • K201543 — MAGEC® System (July 30, 2020)
  • K193016 — PRECICE Bone Transport System (May 8, 2020)
  • K193617 — Precice® Screws (May 8, 2020)
  • K192181 — PRECICE Plating System (November 7, 2019)

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)
  • 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)

FDA data resources