Home / 510(k) Clearances / K220468

510(k) K220468

BENCOX Mirabo Cup System by Corentec Co., Ltd. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2022
Date Received
February 17, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Corentec Co., Ltd.

  • K250889 — EXULT Knee Replacement System (April 17, 2025)
  • K242401 — EXULT Knee Replacement System (September 12, 2024)
  • K242046 — EXULT Knee Replacement System (August 1, 2024)
  • K223828 — BENCOX Delta Option Heads (March 16, 2023)
  • K223223 — BENCOX Mirabo Z Cup Cortinium (February 27, 2023)
  • K222278 — LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation (August 26, 2022)
  • K210614 — BENCOX Mirabo Z Cup Cortinium (May 24, 2022)
  • K212034 — LOSPA TKR System (December 9, 2021)
  • K211866 — Bencox THR System (July 14, 2021)
  • K201851 — EXULT Femoral component trial - Left, EXULT Femoral component trial - Right (July 30, 2020)

Other clearances for product code LPH

  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)