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510(k) K073135

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS by Synthes (Usa) — Product Code LXT

K073135 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS". The FDA issued a decision of Substantially Equivalent on January 29, 2008. 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. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2008
Date Received
November 7, 2007
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 Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

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)
  • 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