Home / 510(k) Clearances / K150885

510(k) K150885

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

K150885 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Incorporated for the device "MAGEC 2 Spinal Bracing and Distraction System". The FDA issued a decision of Substantially Equivalent on May 29, 2015. The device falls under product code PGN (Growing Rod System- Magnetic Actuation), a Class II device regulated under 21 CFR 888.3070. Ellipse Technologies, Incorporated has at least 6 other 510(k) clearances on record.

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

  • K160267 — PRECICE Trauma Nail System (March 31, 2016)
  • 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)

FDA data resources