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510(k) K042059

SHOULDER FIXATION SYSTEM by Hand Innovations, Inc. — Product Code LXT

K042059 is an FDA 510(k) premarket notification submitted by Hand Innovations, Inc. for the device "SHOULDER FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 2004. 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. Hand Innovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2004
Date Received
July 30, 2004
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 Hand Innovations, Inc.

  • K061748 — FRAGMENT PLATE SYSTEM (July 17, 2006)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060294 — DIAPHYSEAL PLATE (March 22, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052294 — SHOULDER NAIL PLATE (October 21, 2005)
  • K052248 — DORSAL NAIL PLATE, ANATOMICAL (September 14, 2005)
  • K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM (July 20, 2005)
  • K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (April 26, 2005)
  • K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM (July 30, 2004)
  • K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (July 1, 2004)

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