Home / 510(k) Clearances / K964163

510(k) K964163

TRIMAX NAIL SYSTEM by Smith & Nephew Richards, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1996
Date Received
October 17, 1996
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 Smith & Nephew Richards, Inc.

  • K965224 — EMPOWER ANTERIOR DIRECT SCREWS (May 8, 1997)
  • K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (January 27, 1997)
  • K960444 — FINN ROD TO ROD CONNECTOR (January 24, 1997)
  • K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (December 5, 1996)
  • K963486 — REVISION HIP SYSTEM (November 27, 1996)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
  • K962137 — GENESIS II CONSTRAINED SYSTEM (August 2, 1996)
  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)
  • K960094 — REFLECTION DUAL DIMENSION SHELL (March 27, 1996)

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)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)