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510(k) K810556

Device
SPINAL EXTENSION BRACE
Applicant
ORTHOMEDICS
510(k) number
K810556
Product code
IPY  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-13
Date received
1981-03-02
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
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 IPY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823882M-BRACEBuckman Consultants1983-01-17
K823823LUMBOSACRAL SUPPORTDanek Medical, Inc.1983-01-14
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
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#

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FDA Review#

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