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510(k) K941048

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR by Applied Osteo Systems, Inc. — Product Code LXT

K941048 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "TRUE/LOK MONOLATERAL/BILATERAL FIXATOR". The FDA issued a decision of Substantially Equivalent on October 3, 1994. 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. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
March 7, 1994
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 Applied Osteo Systems, Inc.

  • K935383 — FEMROD AND FEMROD RECON INSERT (March 21, 1995)
  • K933995 — TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (January 27, 1995)
  • K944501 — TRUE/FLEX INTRAMEDULLARY ROD END-CAP (November 28, 1994)
  • K943160 — INTERFERENCE SCREW (September 30, 1994)
  • K932853 — PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS (February 22, 1994)
  • K934148 — TRUE/FLEX CLAVICLE RODS (February 22, 1994)
  • K931578 — TEXAS SCOTTISH RITE EASY/LOCK FIXATOR (February 22, 1994)
  • K926465 — FEMORAL INTRAMEDULLARY RODS (August 25, 1993)
  • K924657 — TRUE/FLEX METATARSAL RODS (November 24, 1992)
  • K924656 — TRUE/ FLEX FIBULA RODS (November 24, 1992)

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