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Innolitics
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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
QQO
Cranial Measurement Software
1
Product Code
HST
Apparatus, Traction, Non-Powered
1
Product Code
K
16
2702
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
1
Cleared 510(K)
K
11
0858
LO-BAK TRAX
1
Cleared 510(K)
K
98
4190
BACK-ON-TRAC, MODEL 101BOT
1
Cleared 510(K)
K
87
2121
K AND D HOME TRACT
1
Cleared 510(K)
K
87
0212
ARTHROSCOPIC SHOULDER HOLDER
1
Cleared 510(K)
K
87
0125
EXTREMITY ELEVATOR
1
Cleared 510(K)
K
87
0102
TUPPER TROLLEY
1
Cleared 510(K)
K
86
4765
MODEL 668, TRACTION SPLINT, ADULT
1
Cleared 510(K)
K
86
2874
THE TOWERED 90/90 UNIT
1
Cleared 510(K)
K
86
0037
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
1
Cleared 510(K)
K
85
5179
TRANSFER-TRAX (TM) SPLINT TRACTION
1
Cleared 510(K)
K
84
4239
NEC-KRADLE BY VENCOR
1
Cleared 510(K)
K
84
1388
ACUFEX SHOULDER HOLDER
1
Cleared 510(K)
K
84
1368
HYPERBARIC OXYGEN GURNEY-
1
Cleared 510(K)
K
83
1888
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG
1
Cleared 510(K)
K
83
0244
TRACTION ACCESSORIES
1
Cleared 510(K)
K
82
3813
TRACTION ACCESSORIES
1
Cleared 510(K)
K
82
3395
TRACTION-STEEL FRAMING SYSTEM
1
Cleared 510(K)
K
82
3372
OCTAGONAL ALUMINUM FRAMING SYSTEM
1
Cleared 510(K)
K
82
3392
FOREARM REDUCTION UNIT
1
Cleared 510(K)
K
82
2993
SENATEK
1
Cleared 510(K)
K
82
1522
CERVITRAC TRACTION FRAME & CORD
1
Cleared 510(K)
K
82
0612
TENSOPLAST SKIN TRACTION KIT
1
Cleared 510(K)
K
81
3017
NECKTRAC
1
Cleared 510(K)
K
81
3016
ZEE TRACTION SPLINT
1
Cleared 510(K)
K
81
2779
EXTENSIONS-LUSATZTISCH
1
Cleared 510(K)
K
80
3021
UPPER EXTREMITY TRACTION DEVICE
1
Cleared 510(K)
K
80
2555
COTTRELL 90/90 BACKTRAC
1
Cleared 510(K)
K
80
2072
PROT-A-TRAC
1
Cleared 510(K)
K
79
2248
TAYLOR TRACTION CORD
1
Cleared 510(K)
K
79
1919
BAC JAC
1
Cleared 510(K)
K
79
1396
MEDI-TRAK PORTABLE TRACTION DEVICE
1
Cleared 510(K)
K
79
0729
OCTAGONAL ALUMINUM FRAMING SYSTEM
1
Cleared 510(K)
K
77
1988
VERTETRAC
1
Cleared 510(K)
K
78
1647
BACK TRAC
1
Cleared 510(K)
K
78
0233
TRACTION WEIGHT BAGS
1
Cleared 510(K)
K
78
0228
TRACTION UNITS
1
Cleared 510(K)
K
77
0080
BAKER MOBILE TRACTION
1
Cleared 510(K)
ONO
Neurosurgical Laser With Mr Thermography
2
Product Code
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
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 16 August 2024 at 11:05 pm
NE
/
subpart-e—surgical-devices
/
HST
/
K823372
View Source
OCTAGONAL ALUMINUM FRAMING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823372
510(k) Type
Traditional
Applicant
ORTHOPEDIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/3/1982
Days to Decision
21 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
QQO
Cranial Measurement Software
HST
Apparatus, Traction, Non-Powered
K
16
2702
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
K
11
0858
LO-BAK TRAX
K
98
4190
BACK-ON-TRAC, MODEL 101BOT
K
87
2121
K AND D HOME TRACT
K
87
0212
ARTHROSCOPIC SHOULDER HOLDER
K
87
0125
EXTREMITY ELEVATOR
K
87
0102
TUPPER TROLLEY
K
86
4765
MODEL 668, TRACTION SPLINT, ADULT
K
86
2874
THE TOWERED 90/90 UNIT
K
86
0037
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
K
85
5179
TRANSFER-TRAX (TM) SPLINT TRACTION
K
84
4239
NEC-KRADLE BY VENCOR
K
84
1388
ACUFEX SHOULDER HOLDER
K
84
1368
HYPERBARIC OXYGEN GURNEY-
K
83
1888
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG
K
83
0244
TRACTION ACCESSORIES
K
82
3813
TRACTION ACCESSORIES
K
82
3395
TRACTION-STEEL FRAMING SYSTEM
K
82
3372
OCTAGONAL ALUMINUM FRAMING SYSTEM
K
82
3392
FOREARM REDUCTION UNIT
K
82
2993
SENATEK
K
82
1522
CERVITRAC TRACTION FRAME & CORD
K
82
0612
TENSOPLAST SKIN TRACTION KIT
K
81
3017
NECKTRAC
K
81
3016
ZEE TRACTION SPLINT
K
81
2779
EXTENSIONS-LUSATZTISCH
K
80
3021
UPPER EXTREMITY TRACTION DEVICE
K
80
2555
COTTRELL 90/90 BACKTRAC
K
80
2072
PROT-A-TRAC
K
79
2248
TAYLOR TRACTION CORD
K
79
1919
BAC JAC
K
79
1396
MEDI-TRAK PORTABLE TRACTION DEVICE
K
79
0729
OCTAGONAL ALUMINUM FRAMING SYSTEM
K
77
1988
VERTETRAC
K
78
1647
BACK TRAC
K
78
0233
TRACTION WEIGHT BAGS
K
78
0228
TRACTION UNITS
K
77
0080
BAKER MOBILE TRACTION
ONO
Neurosurgical Laser With Mr Thermography
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-e—surgical-devices
/
HST
/
K823372
View Source
OCTAGONAL ALUMINUM FRAMING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823372
510(k) Type
Traditional
Applicant
ORTHOPEDIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/3/1982
Days to Decision
21 days