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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
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Orthopedic
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
HSR
Unit, Traction, Hip, Non-Powered, Non-Penetrating
1
Product Code
HRR
Scissors, Orthopedic, Surgical
1
Product Code
HRT
Stripper, Surgical
1
Product Code
HSP
Splint, Traction
1
Product Code
HSQ
Belt, Pelvic, Traction
1
Product Code
HTH
Protractor
1
Product Code
HTJ
Gauge, Depth
1
Product Code
HTO
Reamer
1
Product Code
HTP
File
1
Product Code
HTQ
Broach
1
Product Code
HTS
Knife, Orthopedic
1
Product Code
HTT
Burr, Orthopedic
1
Product Code
HTW
Bit, Drill
1
Product Code
HTX
Rongeur
1
Product Code
HWA
Impactor
1
Product Code
HWB
Extractor
1
Product Code
HWD
Starter, Bone Screw
1
Product Code
HWI
Corkscrew
1
Product Code
HWJ
Awl
1
Product Code
HWK
Trephine
1
Product Code
HWL
Set, Hollow Mill
1
Product Code
HWN
Instrument, Compression
1
Product Code
HWO
Skid, Bone
1
Product Code
HWP
Punch, Femoral Neck
1
Product Code
HWQ
Passer
1
Product Code
HWR
Driver, Prosthesis
1
Product Code
HWT
Template
1
Product Code
HWW
Countersink
1
Product Code
HWX
Tap, Bone
1
Product Code
HXB
Probe
1
Product Code
HXC
Wrench
1
Product Code
HXE
Fork
1
Product Code
HXG
Tamp
1
Product Code
HXI
Passer, Wire, Orthopedic
1
Product Code
HXJ
Staple Driver
1
Product Code
HXK
Holder, Needle; Orthopedic
1
Product Code
HXN
Applier, Cerclage
1
Product Code
HXO
Pusher, Socket
1
Product Code
HXP
Instrument, Bending Or Contouring
1
Product Code
HXQ
Crimper, Pin
1
Product Code
HXS
Twister, Wire
1
Product Code
HXW
Bender
1
Product Code
HXX
Screwdriver
1
Product Code
HXY
Brace, Drill
1
Product Code
HXZ
Cutter, Wire
1
Product Code
JDX
Instrument, Surgical, Sonic And Accessory/Attachment
2
Product Code
JDY
Evacuator, Vapor, Cement Monomer
1
Product Code
JDZ
Mixer, Cement, For Clinical Use
1
Product Code
KIH
Dispenser, Cement
1
Product Code
KII
Tube, Cement Ventilation
1
Product Code
KIL
Positioner, Socket
1
Product Code
KQZ
Component, Traction, Non-Invasive
1
Product Code
KTZ
Caliper
1
Product Code
LGF
Component, Cast
1
Product Code
K
04
3526
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
1
Cleared 510(K)
K
97
3417
CLINITEX STOCKINETTE
1
Cleared 510(K)
K
97
3420
CLINITEX CAST PADDING
1
Cleared 510(K)
K
95
5320
PROTEC COTTON PADDING BANDAGE
1
Cleared 510(K)
K
93
2507
QUICK-CAST IMMOBILIZER
1
Cleared 510(K)
K
93
1672
CARAPACE STERILE CAST PADDING
1
Cleared 510(K)
K
91
0274
ARTIFLEX(TM)
1
Cleared 510(K)
K
90
3946
COOL CAST(R)
1
Cleared 510(K)
K
89
6634
CARAGLAS XTRA SYNTHETIC CASTING TAPE
1
Cleared 510(K)
K
88
3294
SYNTHETIC CAST TAPE
1
Cleared 510(K)
K
87
4880
COLORED CASTING TAPE CARAGLAS(TM GREEN
1
Cleared 510(K)
K
87
3722
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133
1
Cleared 510(K)
K
87
3718
CHILD WALKING HEEL PRODUCT NO. 4183-132
1
Cleared 510(K)
K
87
3717
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135
1
Cleared 510(K)
K
87
0404
COLORED CASTING TAPE (RED AND BLUE)
1
Cleared 510(K)
K
86
4092
OEC DESIGN ORTHOPEDIC CAST HEEL
1
Cleared 510(K)
K
86
1073
AMERICAN ORTHOPAEDIC VACUUM 0295-250
1
Cleared 510(K)
K
86
1075
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202
1
Cleared 510(K)
K
86
1074
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200
1
Cleared 510(K)
K
85
4554
DELTA-LITE CASTING RESIN
1
Cleared 510(K)
K
85
4341
DELTA-LITE CASTING RESIN
1
Cleared 510(K)
K
84
3780
VENT-A-CAST
1
Cleared 510(K)
K
84
0617
MASTERFOOT CAST HEEL
1
Cleared 510(K)
K
83
3084
MASTERHINGE
1
Cleared 510(K)
K
82
3819
CAST TOE COVER
1
Cleared 510(K)
K
82
3394
WALKING HEEL
1
Cleared 510(K)
K
82
2059
SHOW'RBAG
1
Cleared 510(K)
K
81
2904
STERILE ORTHOPEDIC STOCKINETTE
1
Cleared 510(K)
K
81
0110
COBBLER'S CHIP SPLINTS
1
Cleared 510(K)
K
80
3141
CONPHAR CAST HEELS
1
Cleared 510(K)
K
78
0283
INSERTER, PLUG, BONE, LIDGE
1
Cleared 510(K)
LGG
Instrument, Cast Application/Removal, Manual
1
Product Code
LGH
Instrument, Cast Removal, Ac-Powered
1
Product Code
LXH
Orthopedic Manual Surgical Instrument
1
Product Code
LYQ
Accessories, Fixation, Spinal Intervertebral Body
1
Product Code
LYS
Bone Mill
1
Product Code
LZV
System, Cement Removal Extraction
2
Product Code
OAR
Injector, Vertebroplasty (Does Not Contain Cement)
1
Product Code
OCJ
Spinal Channeling Instrument, Vertebroplasty
1
Product Code
QBO
Instruments Designed For Press-Fit Osteochondral Implants
2
Product Code
HSZ
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
1
Product Code
HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
1
Product Code
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
1
Product Code
LXI
Guide, Drill, Ligament
1
Product Code
OJH
Orthopedic Tray
1
Product Code
PPP
Disposable Joint Aspiration/Injection Kit
1
Product Code
SAM
Battery-Powered Instruments Charged Through Sterile Barriers
1
Product Code
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
OR
/
subpart-e—surgical-devices
/
LGF
/
K864092
View Source
OEC DESIGN ORTHOPEDIC CAST HEEL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864092
510(k) Type
Traditional
Applicant
MILITARY ENGINEERING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1986
Days to Decision
56 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
HSR
Unit, Traction, Hip, Non-Powered, Non-Penetrating
HRR
Scissors, Orthopedic, Surgical
HRT
Stripper, Surgical
HSP
Splint, Traction
HSQ
Belt, Pelvic, Traction
HTH
Protractor
HTJ
Gauge, Depth
HTO
Reamer
HTP
File
HTQ
Broach
HTS
Knife, Orthopedic
HTT
Burr, Orthopedic
HTW
Bit, Drill
HTX
Rongeur
HWA
Impactor
HWB
Extractor
HWD
Starter, Bone Screw
HWI
Corkscrew
HWJ
Awl
HWK
Trephine
HWL
Set, Hollow Mill
HWN
Instrument, Compression
HWO
Skid, Bone
HWP
Punch, Femoral Neck
HWQ
Passer
HWR
Driver, Prosthesis
HWT
Template
HWW
Countersink
HWX
Tap, Bone
HXB
Probe
HXC
Wrench
HXE
Fork
HXG
Tamp
HXI
Passer, Wire, Orthopedic
HXJ
Staple Driver
HXK
Holder, Needle; Orthopedic
HXN
Applier, Cerclage
HXO
Pusher, Socket
HXP
Instrument, Bending Or Contouring
HXQ
Crimper, Pin
HXS
Twister, Wire
HXW
Bender
HXX
Screwdriver
HXY
Brace, Drill
HXZ
Cutter, Wire
JDX
Instrument, Surgical, Sonic And Accessory/Attachment
JDY
Evacuator, Vapor, Cement Monomer
JDZ
Mixer, Cement, For Clinical Use
KIH
Dispenser, Cement
KII
Tube, Cement Ventilation
KIL
Positioner, Socket
KQZ
Component, Traction, Non-Invasive
KTZ
Caliper
LGF
Component, Cast
K
04
3526
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
K
97
3417
CLINITEX STOCKINETTE
K
97
3420
CLINITEX CAST PADDING
K
95
5320
PROTEC COTTON PADDING BANDAGE
K
93
2507
QUICK-CAST IMMOBILIZER
K
93
1672
CARAPACE STERILE CAST PADDING
K
91
0274
ARTIFLEX(TM)
K
90
3946
COOL CAST(R)
K
89
6634
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K
88
3294
SYNTHETIC CAST TAPE
K
87
4880
COLORED CASTING TAPE CARAGLAS(TM GREEN
K
87
3722
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133
K
87
3718
CHILD WALKING HEEL PRODUCT NO. 4183-132
K
87
3717
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135
K
87
0404
COLORED CASTING TAPE (RED AND BLUE)
K
86
4092
OEC DESIGN ORTHOPEDIC CAST HEEL
K
86
1073
AMERICAN ORTHOPAEDIC VACUUM 0295-250
K
86
1075
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202
K
86
1074
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200
K
85
4554
DELTA-LITE CASTING RESIN
K
85
4341
DELTA-LITE CASTING RESIN
K
84
3780
VENT-A-CAST
K
84
0617
MASTERFOOT CAST HEEL
K
83
3084
MASTERHINGE
K
82
3819
CAST TOE COVER
K
82
3394
WALKING HEEL
K
82
2059
SHOW'RBAG
K
81
2904
STERILE ORTHOPEDIC STOCKINETTE
K
81
0110
COBBLER'S CHIP SPLINTS
K
80
3141
CONPHAR CAST HEELS
K
78
0283
INSERTER, PLUG, BONE, LIDGE
LGG
Instrument, Cast Application/Removal, Manual
LGH
Instrument, Cast Removal, Ac-Powered
LXH
Orthopedic Manual Surgical Instrument
LYQ
Accessories, Fixation, Spinal Intervertebral Body
LYS
Bone Mill
LZV
System, Cement Removal Extraction
OAR
Injector, Vertebroplasty (Does Not Contain Cement)
OCJ
Spinal Channeling Instrument, Vertebroplasty
QBO
Instruments Designed For Press-Fit Osteochondral Implants
HSZ
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
LXI
Guide, Drill, Ligament
OJH
Orthopedic Tray
PPP
Disposable Joint Aspiration/Injection Kit
SAM
Battery-Powered Instruments Charged Through Sterile Barriers
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-e—surgical-devices
/
LGF
/
K864092
View Source
OEC DESIGN ORTHOPEDIC CAST HEEL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864092
510(k) Type
Traditional
Applicant
MILITARY ENGINEERING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1986
Days to Decision
56 days