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510(k) K230067

Para-Fix External Fixation System by New Paradigm Biomedical — Product Code LXT

K230067 is an FDA 510(k) premarket notification submitted by New Paradigm Biomedical for the device "Para-Fix External Fixation System". The FDA issued a decision of Substantially Equivalent on September 22, 2023. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
January 9, 2023
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 for product code LXT

  • 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)
  • K052754 — WRIST FUSION PLATE (October 27, 2005)

FDA data resources