Home / 510(k) Clearances / K250197

510(k) K250197

Estremo Fibular Nail by Citieffe S.R.L. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2025
Date Received
January 23, 2025
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 Citieffe S.R.L.

  • K183666 — EBA One Nailing System (November 14, 2019)
  • K181540 — Estremo Citieffe Nailing System (January 16, 2019)
  • K180150 — PL8 Wrist Reconstruction Plate (August 2, 2018)
  • 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)

Other clearances for product code HSB

  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)