Home / 510(k) Clearances / K180150

510(k) K180150

PL8 Wrist Reconstruction Plate by Citieffe S.R.L. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
January 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Citieffe S.R.L.

  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K183666 — EBA One Nailing System (November 14, 2019)
  • K181540 — Estremo Citieffe Nailing System (January 16, 2019)
  • 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 HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)