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510(k) K233593

MAGEC Spinal Bracing and Distraction System by Nuvasive Specialized Orthopedics, Incorporated — Product Code PGN

K233593 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Incorporated for the device "MAGEC Spinal Bracing and Distraction System". The FDA issued a decision of Substantially Equivalent on February 6, 2024. 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, Incorporated has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2024
Date Received
November 8, 2023
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, Incorporated

  • K232267 — Precice Max System (December 15, 2023)
  • K171791 — MAGEC® System (August 31, 2017)
  • K170939 — Supplemental Instrument Trays (August 8, 2017)

Other clearances for product code PGN

  • 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)
  • 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