IPY — Orthosis, Lumbo-Sacral Class I

FDA Device Classification

Classification Details

Product Code
IPY
Device Class
Class I
Regulation Number
890.3490
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K823882buckman consultantsM-BRACEJanuary 17, 1983
K823823danek medicalLUMBOSACRAL SUPPORTJanuary 14, 1983
K812422surgical appliance industriesCUSTOM CONTOUR LUMBOSACRAL ORTHOSISSeptember 14, 1981
K812099david hendricks, c.p.oCASH ORTHOSISAugust 13, 1981
K811494surgical appliance industriesLUMBO-SACRAL FLEXION ORTHOSISJune 16, 1981
K810554orthomedicsLUMBAR FLEXION BRACEMarch 13, 1981
K810556orthomedicsSPINAL EXTENSION BRACEMarch 13, 1981
K803033orthomedicsCRUSADER HYPEREXTENSION BRACEDecember 22, 1980
K801712fred sammonsLUMBOSACRAL SUPPORTS & THORACO-LUMBO-SACAugust 7, 1980
K792269dow corning wrightWRIGHT DOW CORNING SOFTGOODS W/DOWFebruary 5, 1980
K791314vertebraceVERTEBRACE SPINAL SUPPORTSJuly 30, 1979