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510(k) K823397

Device
ANATOMIC FRACTURE BRACE
Applicant
ORTHOPEDIC SYSTEMS, INC.
510(k) number
K823397
Product code
ITQ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-29
Date received
1982-11-12
Regulation
890.3475
Classification name
Joint, Knee, External Brace
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 ITQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831044LIMITED MOTION FUNCTIONAL KNEE BRACEOrthopedic Systems, Inc.1983-06-24
K831310BRACE C.T.Innovation Sports, Inc.1983-05-16
K823658DELUXE KNEE IMMOBILIZER(UNIVERSAL)Warm & Form, Orthopedic Materials1982-12-30
K823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic Materials1982-11-10
K812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, Inc.1981-09-14
K812094AIRCAST PNEUMATIC KNEE BRACEAircast, Inc.1981-08-13
K811689CYLINDER KNEE CAST/SPLINTSurgical Appliance Industries, Inc.1981-06-25
K810222LIMB ORHTOSISMedical Design & Manufacturing Corp.1981-02-04
K802673KNEE BRACE/STABILIZEROmni Scientific, Inc.1980-11-12
K780892FRACTURE BRACINGHosmer Dorrance Corp.1978-06-13
K772268DEMI-WALKER (REGULAR)Med Fusion Systems, Inc.1977-12-20
K772269SETUP WALKER ADJUSTABLEMed Fusion Systems, Inc.1977-12-20
K772270SETUP WALKER OVER TOILET CONSTRUC.Med Fusion Systems, Inc.1977-12-20
K772271WALKER FOLDING ADJUSTABLEMed Fusion Systems, Inc.1977-12-20

Legacy Summary#

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FDA Review#

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