Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- IMKWheelchair, Stair Climbing2Product Code
- IMLArmrest, Wheelchair1Product Code
- IMMFootrest, Wheelchair1Product Code
- IMNClimber, Curb, Wheelchair1Product Code
- IMOHandrim, Wheelchair1Product Code
- IMPCushion, Wheelchair1Product Code
- IMQAttachment, Narrowing, Wheelchair1Product Code
- IMRDevice, Anti-Tip, Wheelchair1Product Code
- QNXExternal Compression Device For Internal Jugular Vein Compression2Product Code
- ILESling, Arm, Overhead Supported1Product Code
- ILGStocking, Elastic1Product Code
- ILHSplint, Hand, And Components1Product Code
- ILISling, Arm1Product Code
- ILPSystem, Communication, Non-Powered1Product Code
- ILQSystem, Communication, Powered2Product Code
- IMSSupport, Head And Trunk, Wheelchair1Product Code
- IMWBrake, Extension, Wheelchair1Product Code
- IMXBoard, Lap, Wheelchair1Product Code
- IMYArmboard, Wheelchair1Product Code
- IMZHolder, Crutch And Cane, Wheelchair1Product Code
- INAHill Holder, Wheelchair1Product Code
- INBAttachment, Commode, Wheelchair1Product Code
- INCCuff, Pusher, Wheelchair1Product Code
- INESling, Overhead Suspension, Wheelchair1Product Code
- INFScale, Platform, Wheelchair1Product Code
- INGElevator, Wheelchair, Portable2Product Code
- INIVehicle, Motorized 3-Wheeled2Product Code
- INKStretcher, Wheeled, Powered2Product Code
- INMChair, With Casters1Product Code
- INNChair, Adjustable, Mechanical1Product Code
- INOChair, Positioning, Electric2Product Code
- INPTips And Pads, Cane, Crutch And Walker1Product Code
- INQTable, Powered1Product Code
- INTPlinth1Product Code
- INWTable, Mechanical1Product Code
- IORWheelchair, Mechanical1Product Code
- IOYSupport, Arm1Product Code
- IOZSplint, Abduction, Congenital Hip Dislocation1Product Code
- IPGShoe, Cast1Product Code
- IPLWheelchair, Standup2Product Code
- IPMCover, Limb1Product Code
- IPOOrthosis, Pneumatic Structure, Rigid3Product Code
- IPRCrutch1Product Code
- IPSCane1Product Code
- IPTOrthosis, Thoracic1Product Code
- IPWOrthosis, Sacroiliac, Soft1Product Code
- IPXOrthosis, Rib Fracture, Soft1Product Code
- IPYOrthosis, Lumbo-Sacral1Product Code
- IQASystem, Environmental Control, Powered2Product Code
- IQBBelt, Wheelchair1Product Code
- IQCWheelchair, Special Grade2Product Code
- IQEOrthosis, Lumbar1Product Code
- IQFOrthosis, Cervical-Thoracic, Rigid1Product Code
- IQIOrthosis, Limb Brace1Product Code
- K143458Neurosplint1Cleared 510(K)
- K052771SENSOR WALK1Cleared 510(K)
- K031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-11Cleared 510(K)
- K926391ACCUFLEX DYNAMIC ELBOW ORTHOSIS1Cleared 510(K)
- K910974MCCONNELL SHOULDER BRACE1Cleared 510(K)
- K874502GAIT-AID ORTHOPEDIC INSOLE1Cleared 510(K)
- K831542ADJUSTABLE POLYCENTRIC ELBOW HINGE1Cleared 510(K)
- K831615DROP FOOT BRACE1Cleared 510(K)
- K823812VARIOUS SUPPORTS AND SPLINTS1Cleared 510(K)
- K823113BRACE-UP ALL PURPOSE WRIST BAND1Cleared 510(K)
- K823160ROTATION BOOT1Cleared 510(K)
- K823114BRACE-UP STOCKING KNEE BRACE1Cleared 510(K)
- K822767UNIVERSAL DYNASPLINT1Cleared 510(K)
- K822022SPORT SUPPORTS1Cleared 510(K)
- K821704FRACTURE BRACING1Cleared 510(K)
- K821641OBTHOSES1Cleared 510(K)
- K821640ORTHOTIC FABRICATION ACCESSORIES1Cleared 510(K)
- K821582WARM'N FORM SPORTS SUPPORTS1Cleared 510(K)
- K820469WARM & FORM KNEE SUPPORTS1Cleared 510(K)
- K811704MULTITUBULAR AIR SPLINT KIT1Cleared 510(K)
- K811690ANKLE-FOOT CAST/SPLINT1Cleared 510(K)
- K811490FOREARM & KNEE STRAPS1Cleared 510(K)
- K811456ORTHO-FRAC KIT1Cleared 510(K)
- K811343HUMERAL FRACTURE CAST BRACE1Cleared 510(K)
- K811035PRO COMFORT TENNIS ELBOW SUPPORT/WRIST1Cleared 510(K)
- K810443LIMB ORTHOSIS1Cleared 510(K)
- K810288AIRCAST TENNIS ARM BAND1Cleared 510(K)
- K802910PLASTIC FRACTURE CAST BRACE KNEE JOINT1Cleared 510(K)
- K802909HUMERAL FRACTURE BRACE1Cleared 510(K)
- K802908ULNAR FRACTURE BRACE1Cleared 510(K)
- K802871TIBIAL FRACTURE BRACE1Cleared 510(K)
- K802104C-SPLINT1Cleared 510(K)
- K801788HUMEROUS FRACTURE BRACE, ULNA FRACTURE1Cleared 510(K)
- K801701BAUER & BLACK RIGID WRIST BRACE1Cleared 510(K)
- K801708BK-1520-01 ECONOMY WRIST SUPPORT, CHILD1Cleared 510(K)
- K800715OHC DYNAMIC CLUB FOOT BRACE1Cleared 510(K)
- K791565PARAPODIUM1Cleared 510(K)
- K791249SECUTEX WRIST BRACE1Cleared 510(K)
- K791267SECUTEX ANKLE BAND1Cleared 510(K)
- K791266SECUTEX KNEE BAND1Cleared 510(K)
- K791248SECUTE ELBOW BAND1Cleared 510(K)
- K791057CAST BRACE COMPONENTS1Cleared 510(K)
- K781206FOOT POSITIONER1Cleared 510(K)
- K780979AIRSTIRRUP PNEUMATIC ANKLE BRACE1Cleared 510(K)
- K780225ORTHOSISES DEVICES1Cleared 510(K)
- K780053BRACE, TENNIS ELBOW1Cleared 510(K)
- K771676FOOT DROP BOOT1Cleared 510(K)
- K770612SPLINT, BOHLER1Cleared 510(K)
- K770167KNEE SEPARATOR1Cleared 510(K)
- K761312ORTHOTIC BRACING1Cleared 510(K)
- K760950DEVON KNEE STRAP1Cleared 510(K)
- K760002KNEE AID1Cleared 510(K)
- IQJSplint, Clavicle1Product Code
- IQKOrthosis, Cervical1Product Code
- IQMSplint, Temporary Training1Product Code
- IQODevice, Prosthesis Alignment1Product Code
- IQPRotator, Transverse1Product Code
- IQQJoint, Shoulder, External Limb Component1Product Code
- IQWHook, External Limb Component, Powered1Product Code
- IQXHook, External Limb Component, Mechanical1Product Code
- IQZHand, External Limb Component, Powered1Product Code
- IRAHand, External Limb Component, Mechanical1Product Code
- IRDJoint, Elbow, External Limb Component, Mechanical1Product Code
- IREJoint, Elbow, External Limb Component, Powered1Product Code
- ISHComponent, External, Limb, Ankle/Foot1Product Code
- ISLJoint, Hip, External Limb Component1Product Code
- ISMPylon, Post Surgical1Product Code
- ISNCable1Product Code
- ISPValve, Prosthesis1Product Code
- ISRBand Or Belt, Pelvic Support1Product Code
- ISSProsthesis, Thigh Socket, External Component1Product Code
- ISWAssembly, Knee/Shank/Ankle/Foot, External2Product Code
- ISYJoint, Knee, External Limb Component1Product Code
- ISZUnit, Wrist, External Limb Component, Mechanical1Product Code
- ITCStirrup, External Brace Component1Product Code
- ITGBandage, Cast1Product Code
- ITIWheelchair, Powered2Product Code
- ITJWalker, Mechanical1Product Code
- ITMCage, Knee1Product Code
- ITNSplint, Denis Brown1Product Code
- ITOTwister, Brace Setting1Product Code
- ITQJoint, Knee, External Brace1Product Code
- ITSJoint, Hip, External Brace1Product Code
- ITWJoint, Ankle, External Brace1Product Code
- KFTAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical1Product Code
- KFWAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered1Product Code
- KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External2Product Code
- KGHUnit, Wrist, External Limb Component, Powered1Product Code
- KHYCane, Safety Walk1Product Code
- KICCushion, Flotation1Product Code
- KIDRestraint, Wheelchair, Non-Protective1Product Code
- KNNComponents, Wheelchair1Product Code
- KNOAccessories, Wheelchair1Product Code
- KNPOrthosis, Corrective Shoe1Product Code
- KTDOrthosis, Abdominal1Product Code
- LBEStroller, Adaptive1Product Code
- LFFUnit, Activation, Breath Control1Product Code
- MNEOrthosis, Moldable, Supportive, Skin Protective1Product Code
- MRIOrthosis, Truncal/Orthosis, Limb1Product Code
- NDAHelmet, Cranial, For Protective Use1Product Code
- NHFMonitor, Orthotic/Prosthetic1Product Code
- NJBOrthosis, Truncal, For Dysmenorrhea1Product Code
- NXEWalker, Mechanical, Poly Vinyl Chloride (Pvc)1Product Code
- OHIOrthosis, Foot Drop1Product Code
- PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography2Product Code
- PCEPermanently Mounted Wheelchair Platform Lift2Product Code
- PMVOrthosis, Limb, For Back Pain1Product Code
- QDTShoe With Adjustable Sole Units1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ORTHO-FRAC KIT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K811456
- 510(k) Type
- Traditional
- Applicant
- ORTHOMEDICS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/12/1981
- Days to Decision
- 21 days