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510(k) K152370

PRECICE Trauma Nail System by Ellipse Technologies, Incorporated — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
August 21, 2015
Clearance Type
Special
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, Incorporated

  • K160267 — PRECICE Trauma Nail System (March 31, 2016)
  • K151594 — Ellipse Supplemental Instrument Trays (January 25, 2016)
  • K151131 — PRECICE Intramedullary Limb Lengthening System (June 19, 2015)
  • K150885 — MAGEC 2 Spinal Bracing and Distraction System (May 29, 2015)
  • K150656 — PRECICE Intramedullary Limb Lengthening System (April 23, 2015)
  • K142599 — PRECISE Trauma Nail System (January 16, 2015)

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