FDA.reportPublic FDA data

510(k) K872121

Device
K And D Home Tract
Applicant
JOSEPH A. KOTT, M.D.
510(k) number
K872121
Product code
HST
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-12
Date received
1987-05-27
Regulation
888.5850
Classification name
Apparatus, Traction, Non-Powered
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
E. Jefferson Medical Ofc Bldg. 4224 Houma Blvd., Suite 460 Metairie LA US 70006 70006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HST#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K110858LO-BAK TRAXRoland F Berthiaume, DC2011-08-02
K984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.1999-03-15
K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.1987-02-20
K870125EXTREMITY ELEVATOROrthopedic Systems, Inc.1987-02-04
K870102TUPPER TROLLEYOrthopedic Systems, Inc.1987-02-03
K864765MODEL 668, TRACTION SPLINT, ADULTFerno-Washington, Inc.1986-12-17
K862874THE TOWERED 90/90 UNITLossing Orthopedic, Inc.1986-08-07
K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICEComfortex, Inc.1986-01-21
K855179TRANSFER-TRAX (TM) SPLINT TRACTIONComfortex, Inc.1986-01-21
K844239NEC-KRADLE BY VENCORVencor1984-11-19
K841388ACUFEX SHOULDER HOLDERAcufex Microsurgical, Inc.1984-05-16
K841368HYPERBARIC OXYGEN GURNEY-Orthopedic Systems, Inc.1984-05-16
K831888COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYGPortable Travtion Device Co.1983-07-12
K830244TRACTION ACCESSORIESWarm & Form, Orthopedic Materials1983-03-09