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510(k) K140613

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

K140613 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Inc. for the device "MAGEC SPINAL BRACING AND DISTRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 18, 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
September 18, 2014
Date Received
March 10, 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)
  • K141447 — PRECICE TRAUMA NAIL SYSTEM (June 30, 2014)
  • K141023 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (May 20, 2014)
  • K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (February 27, 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)
  • K140178 — ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (February 27, 2014)

FDA data resources