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
K
23
2684
Surgify Halo
2
Cleared 510(K)
K
23
0619
Hubly Electric Drill (H100)
2
Cleared 510(K)
K
22
3199
2.1 x 255mm Drill, 22mm Stop
2
Cleared 510(K)
K
21
3072
2.1 x 255mm Drill, 22mm Stop
2
Cleared 510(K)
K
21
3208
Twist Drills
2
Cleared 510(K)
K
21
3454
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
2
Cleared 510(K)
K
20
2120
P300 Attachment
2
Cleared 510(K)
K
20
3739
ELAN 4 Electro Motor System
2
Cleared 510(K)
K
21
0377
Stryker iBur hubs and cutting accessories
2
Cleared 510(K)
K
19
1479
Velocity Alpha Highspeed Surgical Drill System
2
Cleared 510(K)
K
18
3203
ELAN 4 Tools
2
Cleared 510(K)
K
18
3545
Anspach Helix Dissection Tools
2
Cleared 510(K)
K
19
1049
Stryker MIS and Footed Attachments
2
Cleared 510(K)
K
19
0172
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
2
Cleared 510(K)
K
18
2527
ELAN 4 Tools
2
Cleared 510(K)
K
17
2709
ELAN 4 Electro Motor System Tools
2
Cleared 510(K)
K
18
2436
POWEREASE System
2
Cleared 510(K)
K
17
0442
Cranial Drill Bits and Accessories
2
Cleared 510(K)
K
16
2542
OsteoMed PINNACLE Driver
2
Cleared 510(K)
K
16
1704
Phasor Drill
2
Cleared 510(K)
K
15
3519
DReal
2
Cleared 510(K)
K
14
3399
Stryker Footed Attachments and Cutting Accessories
2
Cleared 510(K)
K
14
3540
Stryker MIS Attachments and Cutting Accessories
2
Cleared 510(K)
K
14
3320
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
2
Cleared 510(K)
K
13
0755
HICUT HIGHSPEED INSTRUMENT
2
Cleared 510(K)
K
13
2436
VARIOGUIDE DRILL KIT
2
Cleared 510(K)
K
12
3270
POWEREASE SYSTEM
2
Cleared 510(K)
K
12
1264
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
2
Cleared 510(K)
K
11
3476
ANSPACH DISSECTION TOOLS
2
Cleared 510(K)
K
11
1520
IPC POWEREASE SYSTEM
2
Cleared 510(K)
K
08
1475
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
2
Cleared 510(K)
K
08
0802
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
2
Cleared 510(K)
K
07
2315
MIDAS REX CURVED BUR
2
Cleared 510(K)
K
07
0876
STRYKER TWIST DRILLS
2
Cleared 510(K)
K
06
2842
TWIST DRILL
2
Cleared 510(K)
K
05
0628
ANSPACH COUPLER
2
Cleared 510(K)
K
04
2783
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
2
Cleared 510(K)
K
04
0076
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
2
Cleared 510(K)
K
03
2303
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
2
Cleared 510(K)
K
03
0172
SMALL HIGH SPEED MOTOR DRILL SYSTEM
2
Cleared 510(K)
K
02
2942
CRANIOCUT
2
Cleared 510(K)
K
01
4060
MICROAIRE 1000E SYSTEM
2
Cleared 510(K)
K
00
2903
ANSPACH ANGLED MICRONOSE ATTACHMENT
2
Cleared 510(K)
K
98
4035
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
2
Cleared 510(K)
K
94
3541
75K STAIGHT DRILL
2
Cleared 510(K)
K
93
5861
MEDNEXT BUR
2
Cleared 510(K)
K
93
0229
CLINICAL NEURO SYSTEMS CRANIAL DRILL
2
Cleared 510(K)
K
92
2299
ZEPPELIN MOTOR DRILL SYSTEM
2
Cleared 510(K)
K
91
1812
ACRA-CUT WIRE PASS DRILL
2
Cleared 510(K)
K
91
1819
ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
2
Cleared 510(K)
K
90
5097
MICRO-AIRE MODEL NUMBER: MK-426
2
Cleared 510(K)
K
90
2703
CRANIOTOME BLADE OR DRILL BIT
2
Cleared 510(K)
K
90
3664
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
2
Cleared 510(K)
K
90
0388
MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
2
Cleared 510(K)
K
88
1418
CRANIOTOME BLADE OR NEURO BLADE
2
Cleared 510(K)
K
88
0601
WIRE PASS DRILL BITS
2
Cleared 510(K)
K
87
5224
HUDSON CRANINAL BURRS
2
Cleared 510(K)
K
87
3692
RAYLOR(TM) DRILL STOP
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
NE
/
subpart-e—neurological-surgical-devices
/
HBE
/
K032303
View Source
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K032303
510(k) Type
Traditional
Applicant
STRYKER INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/2004
Days to Decision
175 days
Submission Type
Summary
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)
K
23
2684
Surgify Halo
K
23
0619
Hubly Electric Drill (H100)
K
22
3199
2.1 x 255mm Drill, 22mm Stop
K
21
3072
2.1 x 255mm Drill, 22mm Stop
K
21
3208
Twist Drills
K
21
3454
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
K
20
2120
P300 Attachment
K
20
3739
ELAN 4 Electro Motor System
K
21
0377
Stryker iBur hubs and cutting accessories
K
19
1479
Velocity Alpha Highspeed Surgical Drill System
K
18
3203
ELAN 4 Tools
K
18
3545
Anspach Helix Dissection Tools
K
19
1049
Stryker MIS and Footed Attachments
K
19
0172
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K
18
2527
ELAN 4 Tools
K
17
2709
ELAN 4 Electro Motor System Tools
K
18
2436
POWEREASE System
K
17
0442
Cranial Drill Bits and Accessories
K
16
2542
OsteoMed PINNACLE Driver
K
16
1704
Phasor Drill
K
15
3519
DReal
K
14
3399
Stryker Footed Attachments and Cutting Accessories
K
14
3540
Stryker MIS Attachments and Cutting Accessories
K
14
3320
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K
13
0755
HICUT HIGHSPEED INSTRUMENT
K
13
2436
VARIOGUIDE DRILL KIT
K
12
3270
POWEREASE SYSTEM
K
12
1264
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K
11
3476
ANSPACH DISSECTION TOOLS
K
11
1520
IPC POWEREASE SYSTEM
K
08
1475
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K
08
0802
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
K
07
2315
MIDAS REX CURVED BUR
K
07
0876
STRYKER TWIST DRILLS
K
06
2842
TWIST DRILL
K
05
0628
ANSPACH COUPLER
K
04
2783
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
K
04
0076
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K
03
2303
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K
03
0172
SMALL HIGH SPEED MOTOR DRILL SYSTEM
K
02
2942
CRANIOCUT
K
01
4060
MICROAIRE 1000E SYSTEM
K
00
2903
ANSPACH ANGLED MICRONOSE ATTACHMENT
K
98
4035
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
K
94
3541
75K STAIGHT DRILL
K
93
5861
MEDNEXT BUR
K
93
0229
CLINICAL NEURO SYSTEMS CRANIAL DRILL
K
92
2299
ZEPPELIN MOTOR DRILL SYSTEM
K
91
1812
ACRA-CUT WIRE PASS DRILL
K
91
1819
ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
K
90
5097
MICRO-AIRE MODEL NUMBER: MK-426
K
90
2703
CRANIOTOME BLADE OR DRILL BIT
K
90
3664
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K
90
0388
MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
K
88
1418
CRANIOTOME BLADE OR NEURO BLADE
K
88
0601
WIRE PASS DRILL BITS
K
87
5224
HUDSON CRANINAL BURRS
K
87
3692
RAYLOR(TM) DRILL STOP
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
/
HBE
/
K032303
View Source
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K032303
510(k) Type
Traditional
Applicant
STRYKER INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/2004
Days to Decision
175 days
Submission Type
Summary