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510(k) K052754

WRIST FUSION PLATE by Dvo Extremity Solutions, LLC — Product Code LXT

K052754 is an FDA 510(k) premarket notification submitted by Dvo Extremity Solutions, LLC for the device "WRIST FUSION PLATE". The FDA issued a decision of Substantially Equivalent on October 27, 2005. 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. Dvo Extremity Solutions, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2005
Date Received
September 30, 2005
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 Dvo Extremity Solutions, LLC

  • K073331 — DVO EXTENDED ARTICULATION HUMERAL HEADS (February 19, 2008)
  • K060988 — TOTAL AND HEMI SHOULDER SYSTEM (December 6, 2006)
  • K052150 — VOLAR PLATE SYSTEM (September 8, 2005)

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