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510(k) K131677

PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM by Ellipse Technologies, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
June 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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)
  • 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)
  • K113219 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (October 19, 2012)

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