FDA.reportPublic FDA data

510(k) K823392

Device
FOREARM REDUCTION UNIT
Applicant
ORTHOPEDIC SYSTEMS, INC.
510(k) number
K823392
Product code
HST  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-29
Date received
1982-11-12
Regulation
888.5850
Classification name
Apparatus, Traction, Non-powered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.2016-12-30
K110858LO-BAK TRAXRoland F Berthiaume, DC2011-08-02
K984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.1999-03-15
K872121K AND D HOME TRACTJoseph A. Kott, M.D.1987-08-12
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
K855179TRANSFER-TRAX (TM) SPLINT TRACTIONComfortex, Inc.1986-01-21
K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICEComfortex, Inc.1986-01-21
K844239NEC-KRADLE BY VENCORVencor1984-11-19
K841368HYPERBARIC OXYGEN GURNEY-Orthopedic Systems, Inc.1984-05-16
K841388ACUFEX SHOULDER HOLDERAcufex Microsurgical, Inc.1984-05-16
K831888COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYGPortable Travtion Device Co.1983-07-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases