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510(k) K864403

Device
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
Applicant
HOWMEDICA CORP.
510(k) number
K864403
Product code
LXT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-12-18
Date received
1986-11-10
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT E SMITH
Address
359 Veterans Blvd. Rutherford NJ US 07070 07070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230067Para-Fix External Fixation SystemNew Paradigm Biomedical2023-09-22
K131636POLARUS CONNECTAcumed, LLC2013-10-10
K132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiomet2013-10-09
K112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL2011-10-31
K090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.2009-03-11
K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)2008-01-29
K063832SYNTHES (USA) ELBOW HINGE FIXATORSynthes (Usa)2007-03-07
K060864MULTIDIRECTIONAL THREADED PEGHand Innovations, LLC2006-04-28
K060403PTA (PROGRESSIVE TIBIAL ALIGNMENT)Meridian Medical2006-03-28
K060290SHOULDER FIXATION SYSTEMHand Innovations, LLC2006-02-27
K052754WRIST FUSION PLATEDvo Extremity Solutions, LLC2005-10-27
K051728MODIFICATION TO SHOULDER FIXATION SYSTEMHand Innovations, LLC2005-07-20
K051306HOFFMANN II MRI EXTERNAL FIXATION SYSTEMHowmedica Osteonics Corp.2005-06-17
K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMHand Innovations, Inc.2005-04-26
K050631SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSIONSynthes (Usa)2005-04-11

Legacy Summary#

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FDA Review#

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