Home / 510(k) Clearances / K953397

510(k) K953397

HEX-FIX FIELD FIXATOR by Smith & Nephew Richards, Inc. — Product Code LXT

K953397 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "HEX-FIX FIELD FIXATOR". The FDA issued a decision of Substantially Equivalent on October 31, 1995. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1995
Date Received
July 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device Class
Class II
Regulation Number
888.3030
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)
  • K964163 — TRIMAX NAIL SYSTEM (December 27, 1996)
  • 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)

Other clearances for product code LXT

  • K230067 — Para-Fix External Fixation System (September 22, 2023)
  • K131636 — POLARUS CONNECT (October 10, 2013)
  • K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (October 9, 2013)
  • K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS (October 31, 2011)
  • K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 (March 11, 2009)
  • K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (January 29, 2008)
  • K063832 — SYNTHES (USA) ELBOW HINGE FIXATOR (March 7, 2007)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT) (March 28, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)

FDA data resources