FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
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
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
K
24
0567
CustomizedBone Service
2
Cleared 510(K)
K
23
1920
Longeviti ClearFit OTS Cranial Implant
2
Cleared 510(K)
K
21
4109
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
2
Cleared 510(K)
K
22
0357
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
2
Cleared 510(K)
K
21
0099
Meticuly Patient-Specific Titanium Mesh Implant
2
Cleared 510(K)
K
21
2058
Longeviti ClearFit™ OTS Cranial Implants
2
Cleared 510(K)
K
21
0616
Longeviti PMMA Static Cranial Implant
2
Cleared 510(K)
K
20
3349
Longeviti ClearFit Cranial Implant
2
Cleared 510(K)
K
20
2901
Longeviti ClearFit Cranial Implant
2
Cleared 510(K)
K
19
2702
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
2
Cleared 510(K)
K
19
3547
CustomizedBone Service
2
Cleared 510(K)
K
19
1210
Longeviti ClearFit Cranial Implant
2
Cleared 510(K)
K
18
0064
OsteoFab Patient Specific Cranial Device
2
Cleared 510(K)
K
18
0513
CustomizedBone Service
2
Cleared 510(K)
K
17
0410
Longeviti PMMA Static Cranial Implant
2
Cleared 510(K)
K
17
1507
CustomizedBone Service
2
Cleared 510(K)
K
16
1090
Cranial PSI
2
Cleared 510(K)
K
16
0707
CustomizedBone Service
2
Cleared 510(K)
K
15
1692
BioArchitects Patient Specific Cranial/Craniofacial Plate
2
Cleared 510(K)
K
15
1382
Patient Contoured Implant-PEEK (PCI-PEEK)
2
Cleared 510(K)
K
13
0447
SPEEDY FLAP SYSTEM
2
Cleared 510(K)
K
13
3082
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
2
Cleared 510(K)
K
12
1818
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
2
Cleared 510(K)
K
12
1755
CUSTOM CRANIOFACIAL IMPLANT (CCI)
2
Cleared 510(K)
K
12
2353
CRAINFIX 2 TITANIUM CLAMP SYSTEM
2
Cleared 510(K)
K
12
1102
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
2
Cleared 510(K)
K
11
0684
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
2
Cleared 510(K)
K
10
3582
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
2
Cleared 510(K)
K
08
2175
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
2
Cleared 510(K)
K
07
2707
PATIENT CONTOURED MESH-PEEK (PCM-P)
2
Cleared 510(K)
K
07
0901
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
2
Cleared 510(K)
K
06
2819
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
2
Cleared 510(K)
K
06
2857
KLS MARTIN QUICK DISC
2
Cleared 510(K)
K
06
2570
PATIENT CONTOURED MESH (PCM)
2
Cleared 510(K)
K
05
2871
STRYKER CUSTOM TI IMPLANT
2
Cleared 510(K)
K
05
3199
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
2
Cleared 510(K)
K
03
3868
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
2
Cleared 510(K)
K
04
0864
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
2
Cleared 510(K)
K
03
1034
SPIN DOWN RAPIDFLAP
2
Cleared 510(K)
K
02
2277
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
2
Cleared 510(K)
K
03
0378
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
2
Cleared 510(K)
K
02
0088
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
2
Cleared 510(K)
K
01
3050
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
2
Cleared 510(K)
K
01
3000
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
2
Cleared 510(K)
K
99
3990
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
2
Cleared 510(K)
K
99
2000
SYNTHES CRANIAL FLAP TUBE CLAMP
2
Cleared 510(K)
K
99
1860
SYNTHES CRANIAL FLAP TWIST CLAMP
2
Cleared 510(K)
K
99
1029
RAPIDFLAP CRANIAL CLAMP
2
Cleared 510(K)
K
97
1252
SEVRAIN CRANIAL CLAMP
2
Cleared 510(K)
K
97
1408
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
2
Cleared 510(K)
K
97
2332
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
2
Cleared 510(K)
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
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-f—neurological-therapeutic-devices
/
GXN
/
K971408
View Source
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971408
510(k) Type
Traditional
Applicant
IKONOS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/1998
Days to Decision
391 days
Submission Type
Statement
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
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
K
24
0567
CustomizedBone Service
K
23
1920
Longeviti ClearFit OTS Cranial Implant
K
21
4109
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K
22
0357
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
K
21
0099
Meticuly Patient-Specific Titanium Mesh Implant
K
21
2058
Longeviti ClearFit™ OTS Cranial Implants
K
21
0616
Longeviti PMMA Static Cranial Implant
K
20
3349
Longeviti ClearFit Cranial Implant
K
20
2901
Longeviti ClearFit Cranial Implant
K
19
2702
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K
19
3547
CustomizedBone Service
K
19
1210
Longeviti ClearFit Cranial Implant
K
18
0064
OsteoFab Patient Specific Cranial Device
K
18
0513
CustomizedBone Service
K
17
0410
Longeviti PMMA Static Cranial Implant
K
17
1507
CustomizedBone Service
K
16
1090
Cranial PSI
K
16
0707
CustomizedBone Service
K
15
1692
BioArchitects Patient Specific Cranial/Craniofacial Plate
K
15
1382
Patient Contoured Implant-PEEK (PCI-PEEK)
K
13
0447
SPEEDY FLAP SYSTEM
K
13
3082
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K
12
1818
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K
12
1755
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K
12
2353
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K
12
1102
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
K
11
0684
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
K
10
3582
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
K
08
2175
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
K
07
2707
PATIENT CONTOURED MESH-PEEK (PCM-P)
K
07
0901
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K
06
2819
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K
06
2857
KLS MARTIN QUICK DISC
K
06
2570
PATIENT CONTOURED MESH (PCM)
K
05
2871
STRYKER CUSTOM TI IMPLANT
K
05
3199
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K
03
3868
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K
04
0864
CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
K
03
1034
SPIN DOWN RAPIDFLAP
K
02
2277
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K
03
0378
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K
02
0088
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K
01
3050
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K
01
3000
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K
99
3990
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K
99
2000
SYNTHES CRANIAL FLAP TUBE CLAMP
K
99
1860
SYNTHES CRANIAL FLAP TWIST CLAMP
K
99
1029
RAPIDFLAP CRANIAL CLAMP
K
97
1252
SEVRAIN CRANIAL CLAMP
K
97
1408
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K
97
2332
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
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-f—neurological-therapeutic-devices
/
GXN
/
K971408
View Source
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971408
510(k) Type
Traditional
Applicant
IKONOS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/1998
Days to Decision
391 days
Submission Type
Statement