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
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
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
K
24
0319
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
2
Cleared 510(K)
K
20
3505
DORO QR3 Headrest System (Aluminum)
2
Cleared 510(K)
K
19
3438
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
2
Cleared 510(K)
K
19
1740
DORO LUCENT® iXI and iMRI Headrest System
2
Cleared 510(K)
K
19
1701
Arcus Head Fixation Frame
2
Cleared 510(K)
K
19
1979
DORO QR3 XTom Headholder System
2
Cleared 510(K)
K
16
3322
TZ SKULL PIN Adult
2
Cleared 510(K)
K
14
2238
MAYFIELD Skull Clamp
2
Cleared 510(K)
K
14
1950
HFD100 ROCKER ARM ACCESSORY
2
Cleared 510(K)
K
12
2225
STERILE RADIOLUCENT SKULL PINS
2
Cleared 510(K)
K
13
0389
MAYFIELD INFINITY XR2 SKULL CLAMP
2
Cleared 510(K)
K
12
0633
MAYFIELD SKULL CLAMP
2
Cleared 510(K)
K
11
3748
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
2
Cleared 510(K)
K
10
3493
HEAD FIATION DEVICE (HFD 100)
2
Cleared 510(K)
K
08
3803
FIXIT HEADREST CLAMP SYSTEM
2
Cleared 510(K)
K
09
1439
HEAD FIXATION ARC AND TABLE BASE
2
Cleared 510(K)
K
09
0695
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
2
Cleared 510(K)
K
09
0506
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
2
Cleared 510(K)
K
08
1401
MAYFIELD MR/X-RAY SKULL CLAMP
2
Cleared 510(K)
K
07
3163
LIMITED ARTIFACT SKULL PIN, MODEL 0107
2
Cleared 510(K)
K
07
2208
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
2
Cleared 510(K)
K
07
1458
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
2
Cleared 510(K)
K
06
3494
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
2
Cleared 510(K)
K
05
3045
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
2
Cleared 510(K)
K
05
1440
MAYFIELD INFINITY SKULL CLAMP
2
Cleared 510(K)
K
05
0319
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
2
Cleared 510(K)
K
03
2331
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
2
Cleared 510(K)
K
03
1885
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
2
Cleared 510(K)
K
02
1604
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
2
Cleared 510(K)
K
00
2990
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
2
Cleared 510(K)
K
00
2276
PSI SKULL CLAMP
2
Cleared 510(K)
K
00
1808
DORO HEADREST SYSTEM
2
Cleared 510(K)
K
95
5012
MIZUHO RADIOLUCENT HEAD FRAME
2
Cleared 510(K)
K
95
3124
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
2
Cleared 510(K)
K
94
1558
MAYFIELD CHILD DISPOSABLE SKULL PIN
2
Cleared 510(K)
K
93
4289
MAYFIELD RADIOLUCENT SKULL CLAMP
2
Cleared 510(K)
K
93
2860
MAYFIELD ADULT DISPOSABLE SKULL PIN
2
Cleared 510(K)
K
93
2807
MAYFIELD* A-2000 SKULL CLAMP
2
Cleared 510(K)
K
92
3789
MAYFIELD ADULT DISPOSABLE SKULL PIN
2
Cleared 510(K)
K
91
2005
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
2
Cleared 510(K)
K
91
1723
CODMAN DISPOSABLE SKULL PINS
2
Cleared 510(K)
K
91
3170
CODMAN SKULL CLAMP
2
Cleared 510(K)
K
91
1772
GARDNER PINS (ADULT & CHILD)
2
Cleared 510(K)
K
91
2011
CODMAN SKULL CLAMP
2
Cleared 510(K)
K
90
1393
MAINZ HEAD FIXATION BY PERNECZKY
2
Cleared 510(K)
K
89
3911
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
2
Cleared 510(K)
K
87
4298
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
2
Cleared 510(K)
K
82
1772
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
2
Cleared 510(K)
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
/
HBL
/
K893911
View Source
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893911
510(k) Type
Traditional
Applicant
MEDICAL EQUIPMENT DEVELOPMENT CO., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/1989
Days to Decision
91 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
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
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)
K
24
0319
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
K
20
3505
DORO QR3 Headrest System (Aluminum)
K
19
3438
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
K
19
1740
DORO LUCENT® iXI and iMRI Headrest System
K
19
1701
Arcus Head Fixation Frame
K
19
1979
DORO QR3 XTom Headholder System
K
16
3322
TZ SKULL PIN Adult
K
14
2238
MAYFIELD Skull Clamp
K
14
1950
HFD100 ROCKER ARM ACCESSORY
K
12
2225
STERILE RADIOLUCENT SKULL PINS
K
13
0389
MAYFIELD INFINITY XR2 SKULL CLAMP
K
12
0633
MAYFIELD SKULL CLAMP
K
11
3748
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
K
10
3493
HEAD FIATION DEVICE (HFD 100)
K
08
3803
FIXIT HEADREST CLAMP SYSTEM
K
09
1439
HEAD FIXATION ARC AND TABLE BASE
K
09
0695
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
K
09
0506
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K
08
1401
MAYFIELD MR/X-RAY SKULL CLAMP
K
07
3163
LIMITED ARTIFACT SKULL PIN, MODEL 0107
K
07
2208
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K
07
1458
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K
06
3494
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
K
05
3045
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K
05
1440
MAYFIELD INFINITY SKULL CLAMP
K
05
0319
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
K
03
2331
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
K
03
1885
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K
02
1604
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K
00
2990
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
K
00
2276
PSI SKULL CLAMP
K
00
1808
DORO HEADREST SYSTEM
K
95
5012
MIZUHO RADIOLUCENT HEAD FRAME
K
95
3124
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K
94
1558
MAYFIELD CHILD DISPOSABLE SKULL PIN
K
93
4289
MAYFIELD RADIOLUCENT SKULL CLAMP
K
93
2860
MAYFIELD ADULT DISPOSABLE SKULL PIN
K
93
2807
MAYFIELD* A-2000 SKULL CLAMP
K
92
3789
MAYFIELD ADULT DISPOSABLE SKULL PIN
K
91
2005
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K
91
1723
CODMAN DISPOSABLE SKULL PINS
K
91
3170
CODMAN SKULL CLAMP
K
91
1772
GARDNER PINS (ADULT & CHILD)
K
91
2011
CODMAN SKULL CLAMP
K
90
1393
MAINZ HEAD FIXATION BY PERNECZKY
K
89
3911
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
K
87
4298
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
K
82
1772
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
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
/
HBL
/
K893911
View Source
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893911
510(k) Type
Traditional
Applicant
MEDICAL EQUIPMENT DEVELOPMENT CO., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/1989
Days to Decision
91 days