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510(k) K163323

Dolphix® External Fixation System MR Conditional by Citieffe S.R.L. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2017
Date Received
November 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K180150 — PL8 Wrist Reconstruction Plate (August 2, 2018)
  • 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)

Other clearances for product code KTT

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  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)
  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)