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510(k) K140178

ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM by Ellipse Technologies, Inc. — Product Code PGN

K140178 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Inc. for the device "ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 2014. The device falls under product code PGN (Growing Rod System- Magnetic Actuation), a Class II device regulated under 21 CFR 888.3070. Ellipse Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2014
Date Received
January 24, 2014
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, Inc.

  • K160325 — PRECICE Intramedullary Limb Lengthening System (April 4, 2016)
  • K141278 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (March 24, 2015)
  • K141739 — RESIDUAL LIMB LENGTHENING SYSTEM (October 7, 2014)
  • K140613 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (September 18, 2014)
  • K141447 — PRECICE TRAUMA NAIL SYSTEM (June 30, 2014)
  • K141023 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (May 20, 2014)
  • K131490 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (January 23, 2014)
  • K133289 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (December 9, 2013)
  • K131677 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (October 11, 2013)
  • K113219 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (October 19, 2012)

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)
  • 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)

FDA data resources