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510(k) K812064

Device
POLI-AXIAL KNEE CAGE
Applicant
GENERATION II ORTHOTICS, INC.
510(k) number
K812064
Product code
ITM  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-13
Date received
1981-07-21
Regulation
890.3475
Classification name
Cage, Knee
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 ITM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832742EXTENSION CONTROL KNEE ORTHOSISOrthomedics1983-09-20
K770899FRACTURE CAST BRACE, POLYChase Mfg. Co.1977-07-21
K770900CAST BRWM, FRACTUREChase Mfg. Co.1977-07-21
K760573IMPROVED KNEE DRESSINGRichard'S Medical Equip., Inc.1976-10-05

Legacy Summary#

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FDA Review#

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