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510(k) K181540

Estremo Citieffe Nailing System by Citieffe S.R.L. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2019
Date Received
June 11, 2018
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

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  • K163323 — Dolphix® External Fixation System MR Conditional (March 20, 2017)
  • K150661 — ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (July 7, 2015)
  • K132363 — DOLPHIX EXTERNAL FIXATION SYSTEM (January 16, 2014)
  • K131005 — EBA2 FEMORAL NAILING SYSTEM (June 25, 2013)
  • K113388 — CITIEFFE-TITANIUM CANNULATED SCREW (June 5, 2012)
  • K113384 — EXTERNAL FIXATOR ST.A R 90 F4 (May 1, 2012)
  • K113387 — CITIEFFE TITANIUM NAILING SYSTEM (March 15, 2012)

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