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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
GXD
Generator, Lesion, Radiofrequency
2
Product Code
GXE
Leukotome
1
Product Code
GXH
Device, Surgical, Cryogenic
2
Product Code
GXI
Probe, Radiofrequency Lesion
2
Product Code
GXJ
Punch, Skull
1
Product Code
GXL
Screwdriver, Skullplate
1
Product Code
GXM
Anvil, Skull Plate
1
Product Code
GYK
Instrument, Shunt System Implantation
1
Product Code
GZQ
Instrument, Dowel Cutting
2
Product Code
GZT
Retractor, Self-Retaining, For Neurosurgery
2
Product Code
K
21
0615
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
2
Cleared 510(K)
K
20
2694
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
2
Cleared 510(K)
K
20
2072
MindsEye Expandable Port
2
Cleared 510(K)
K
18
0610
Geister retractor for neuro - and spine surgery
2
Cleared 510(K)
K
17
2433
NICO BrainPath
2
Cleared 510(K)
K
16
1680
MEDICON Spinal Spreading Systems
2
Cleared 510(K)
K
16
1318
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
2
Cleared 510(K)
K
16
1004
Self-retaining Retractor
2
Cleared 510(K)
K
15
0378
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
2
Cleared 510(K)
K
12
0691
BRAIN PORT
2
Cleared 510(K)
K
11
3273
SPOTLIGHT ACCESS SYSTEM
2
Cleared 510(K)
K
11
2913
SPOTLIGHT ACCESS SYSTEM
2
Cleared 510(K)
K
09
3054
SCALP DURA RETRACTOR, MODEL KS00474
2
Cleared 510(K)
K
09
0272
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
2
Cleared 510(K)
K
07
1771
INSTRUMED RETRACTORS
2
Cleared 510(K)
K
07
1338
FLEX ARM RETRACTOR SYSTEM
2
Cleared 510(K)
K
06
2814
PIPELINE II ACCESS SYSTEM
2
Cleared 510(K)
K
06
0973
VYCOR SURGICAL ACCESS SYSTEMS
2
Cleared 510(K)
K
06
0097
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
2
Cleared 510(K)
K
05
0706
HARMONY PORT SYSTEM, MODEL 1907 SERIES
2
Cleared 510(K)
K
99
2898
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
2
Cleared 510(K)
K
96
4402
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
2
Cleared 510(K)
K
96
0807
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
2
Cleared 510(K)
K
94
5040
HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
2
Cleared 510(K)
K
93
5529
CERVICAL SELF-RETAINING RETRACTOR
2
Cleared 510(K)
K
92
4876
TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
2
Cleared 510(K)
K
91
3233
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
2
Cleared 510(K)
K
91
0621
BLADES FOR SPINAL LAMINECTOMY RETRACTOR
2
Cleared 510(K)
K
90
5445
ADSON-BECKMAN RETRACTOR, SPINAL
2
Cleared 510(K)
K
90
2517
NEUROSURGICAL HEADFRAME ACCESSORIES
2
Cleared 510(K)
K
88
5120
ESI MODEL MS-103
2
Cleared 510(K)
K
89
6156
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
2
Cleared 510(K)
K
89
5395
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
2
Cleared 510(K)
K
89
5537
MODIFIED MEMORY RETRACTOR ARM
2
Cleared 510(K)
K
89
2543
NEUROSURICAL RETRACTORS - VARIOUS TYPES
2
Cleared 510(K)
K
88
2071
CRANK FRAME RETRACTOR
2
Cleared 510(K)
K
88
1160
CRANK FRAME RETRACTOR
2
Cleared 510(K)
K
87
4829
MEDCO MEMORY RETRACTOR SYSTEM
2
Cleared 510(K)
K
87
4956
SELF-RETAINING RETRACTOR FOR NEUROSURGERY
2
Cleared 510(K)
K
87
3691
CEDAR(TM) RETRACTOR RING
2
Cleared 510(K)
K
83
0332
BUDDE-HALO RETRACTOR
2
Cleared 510(K)
K
80
1855
CYCLOPAC TENS
2
Cleared 510(K)
K
80
1151
DISPOSABLE SKIN RETRACTOR
2
Cleared 510(K)
GZX
Instrument, Microsurgical
1
Product Code
HAD
Rongeur, Powered
2
Product Code
HAE
Rongeur, Manual
2
Product Code
HAO
Instrument, Surgical, Non-Powered
1
Product Code
HAS
Needle, Neurosurgical Suture
1
Product Code
HAW
Neurological Stereotaxic Instrument
2
Product Code
HBA
Neurosurgical Paddie
2
Product Code
HBB
Motor, Drill, Pneumatic
2
Product Code
HBC
Motor, Drill, Electric
2
Product Code
HBD
Handpiece (Brace), Drill
1
Product Code
HBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
2
Product Code
HBF
Drills, Burrs, Trephines & Accessories (Compound, Powered)
2
Product Code
HBG
Drills, Burrs, Trephines & Accessories (Manual)
2
Product Code
HBL
Holder, Head, Neurosurgical (Skull Clamp)
2
Product Code
HBM
Headrest, Neurosurgical
1
Product Code
HBN
Chair, Neurosurgical
1
Product Code
HBO
Clip, Scalp
2
Product Code
HBQ
Instrument, Clip Removal
1
Product Code
HBR
Rack, Clip
1
Product Code
HBS
Instrument, Clip Forming/Cutting
1
Product Code
HBX
Instrument, Cranioplasty Material Forming
1
Product Code
HCA
Catheter, Ventricular
2
Product Code
HCD
Cannula, Ventricular
1
Product Code
HCI
Applier, Aneurysm Clip
2
Product Code
NHC
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
2
Product Code
NLN
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
2
Product Code
NLO
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
2
Product Code
NLP
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
2
Product Code
NMN
Instrument, Clip, Forming/Cutting, Reprocessed
1
Product Code
OJG
Neurological Tray
1
Product Code
ORR
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
2
Product Code
PIY
Stainless Steel Instrument, Shunt System Implantation
1
Product Code
PPT
Cranial Surgical Planning And Instrument Guides
2
Product Code
PVM
Endoscopic Ventricular Catheter Placement Kit
2
Product Code
QFX
Diagnostic Neurosurgical Microscope Filter
2
Product Code
QRI
Surgical Planning Software For Neurological Stereotaxic Instruments
2
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
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—neurological-surgical-devices
/
GZT
/
K964402
View Source
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964402
510(k) Type
Traditional
Applicant
V. MUELLER NEURO/SPINE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/1997
Days to Decision
80 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
GXD
Generator, Lesion, Radiofrequency
GXE
Leukotome
GXH
Device, Surgical, Cryogenic
GXI
Probe, Radiofrequency Lesion
GXJ
Punch, Skull
GXL
Screwdriver, Skullplate
GXM
Anvil, Skull Plate
GYK
Instrument, Shunt System Implantation
GZQ
Instrument, Dowel Cutting
GZT
Retractor, Self-Retaining, For Neurosurgery
K
21
0615
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
K
20
2694
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
K
20
2072
MindsEye Expandable Port
K
18
0610
Geister retractor for neuro - and spine surgery
K
17
2433
NICO BrainPath
K
16
1680
MEDICON Spinal Spreading Systems
K
16
1318
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
K
16
1004
Self-retaining Retractor
K
15
0378
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K
12
0691
BRAIN PORT
K
11
3273
SPOTLIGHT ACCESS SYSTEM
K
11
2913
SPOTLIGHT ACCESS SYSTEM
K
09
3054
SCALP DURA RETRACTOR, MODEL KS00474
K
09
0272
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K
07
1771
INSTRUMED RETRACTORS
K
07
1338
FLEX ARM RETRACTOR SYSTEM
K
06
2814
PIPELINE II ACCESS SYSTEM
K
06
0973
VYCOR SURGICAL ACCESS SYSTEMS
K
06
0097
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K
05
0706
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K
99
2898
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K
96
4402
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
K
96
0807
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
K
94
5040
HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
K
93
5529
CERVICAL SELF-RETAINING RETRACTOR
K
92
4876
TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
K
91
3233
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
K
91
0621
BLADES FOR SPINAL LAMINECTOMY RETRACTOR
K
90
5445
ADSON-BECKMAN RETRACTOR, SPINAL
K
90
2517
NEUROSURGICAL HEADFRAME ACCESSORIES
K
88
5120
ESI MODEL MS-103
K
89
6156
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
K
89
5395
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K
89
5537
MODIFIED MEMORY RETRACTOR ARM
K
89
2543
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K
88
2071
CRANK FRAME RETRACTOR
K
88
1160
CRANK FRAME RETRACTOR
K
87
4829
MEDCO MEMORY RETRACTOR SYSTEM
K
87
4956
SELF-RETAINING RETRACTOR FOR NEUROSURGERY
K
87
3691
CEDAR(TM) RETRACTOR RING
K
83
0332
BUDDE-HALO RETRACTOR
K
80
1855
CYCLOPAC TENS
K
80
1151
DISPOSABLE SKIN RETRACTOR
GZX
Instrument, Microsurgical
HAD
Rongeur, Powered
HAE
Rongeur, Manual
HAO
Instrument, Surgical, Non-Powered
HAS
Needle, Neurosurgical Suture
HAW
Neurological Stereotaxic Instrument
HBA
Neurosurgical Paddie
HBB
Motor, Drill, Pneumatic
HBC
Motor, Drill, Electric
HBD
Handpiece (Brace), Drill
HBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
HBF
Drills, Burrs, Trephines & Accessories (Compound, Powered)
HBG
Drills, Burrs, Trephines & Accessories (Manual)
HBL
Holder, Head, Neurosurgical (Skull Clamp)
HBM
Headrest, Neurosurgical
HBN
Chair, Neurosurgical
HBO
Clip, Scalp
HBQ
Instrument, Clip Removal
HBR
Rack, Clip
HBS
Instrument, Clip Forming/Cutting
HBX
Instrument, Cranioplasty Material Forming
HCA
Catheter, Ventricular
HCD
Cannula, Ventricular
HCI
Applier, Aneurysm Clip
NHC
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
NLN
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
NLO
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
NLP
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
NMN
Instrument, Clip, Forming/Cutting, Reprocessed
OJG
Neurological Tray
ORR
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
PIY
Stainless Steel Instrument, Shunt System Implantation
PPT
Cranial Surgical Planning And Instrument Guides
PVM
Endoscopic Ventricular Catheter Placement Kit
QFX
Diagnostic Neurosurgical Microscope Filter
QRI
Surgical Planning Software For Neurological Stereotaxic Instruments
Subpart E—Surgical Devices
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—neurological-surgical-devices
/
GZT
/
K964402
View Source
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964402
510(k) Type
Traditional
Applicant
V. MUELLER NEURO/SPINE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/1997
Days to Decision
80 days
Submission Type
Statement