FDA.reportPublic FDA data

510(k) K823823

Device
LUMBOSACRAL SUPPORT
Applicant
DANEK MEDICAL, INC.
510(k) number
K823823
Product code
IPY  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-14
Date received
1982-12-17
Regulation
890.3490
Classification name
Orthosis, Lumbo-sacral
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IPY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823882M-BRACEBuckman Consultants1983-01-17
K812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISSurgical Appliance Industries, Inc.1981-09-14
K812099CASH ORTHOSISDavid Hendricks, C.P.O.1981-08-13
K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.1981-06-16
K810554LUMBAR FLEXION BRACEOrthomedics1981-03-13
K810556SPINAL EXTENSION BRACEOrthomedics1981-03-13
K803033CRUSADER HYPEREXTENSION BRACEOrthomedics1980-12-22
K801712LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SACFred Sammons, Inc.1980-08-07
K792269WRIGHT DOW CORNING SOFTGOODS W/DOWDow Corning Wright1980-02-05
K791314VERTEBRACE SPINAL SUPPORTSVertebrace, Inc.1979-07-30

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