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Innolitics
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Review Panel
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Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
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Immunology
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Microbiology
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Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
HSR
Unit, Traction, Hip, Non-Powered, Non-Penetrating
1
Product Code
HRR
Scissors, Orthopedic, Surgical
1
Product Code
HRT
Stripper, Surgical
1
Product Code
HSP
Splint, Traction
1
Product Code
HSQ
Belt, Pelvic, Traction
1
Product Code
HTH
Protractor
1
Product Code
HTJ
Gauge, Depth
1
Product Code
HTO
Reamer
1
Product Code
HTP
File
1
Product Code
HTQ
Broach
1
Product Code
HTS
Knife, Orthopedic
1
Product Code
HTT
Burr, Orthopedic
1
Product Code
HTW
Bit, Drill
1
Product Code
HTX
Rongeur
1
Product Code
HWA
Impactor
1
Product Code
HWB
Extractor
1
Product Code
HWD
Starter, Bone Screw
1
Product Code
HWI
Corkscrew
1
Product Code
HWJ
Awl
1
Product Code
HWK
Trephine
1
Product Code
HWL
Set, Hollow Mill
1
Product Code
HWN
Instrument, Compression
1
Product Code
HWO
Skid, Bone
1
Product Code
HWP
Punch, Femoral Neck
1
Product Code
HWQ
Passer
1
Product Code
HWR
Driver, Prosthesis
1
Product Code
HWT
Template
1
Product Code
HWW
Countersink
1
Product Code
HWX
Tap, Bone
1
Product Code
HXB
Probe
1
Product Code
HXC
Wrench
1
Product Code
HXE
Fork
1
Product Code
HXG
Tamp
1
Product Code
HXI
Passer, Wire, Orthopedic
1
Product Code
HXJ
Staple Driver
1
Product Code
HXK
Holder, Needle; Orthopedic
1
Product Code
HXN
Applier, Cerclage
1
Product Code
HXO
Pusher, Socket
1
Product Code
HXP
Instrument, Bending Or Contouring
1
Product Code
HXQ
Crimper, Pin
1
Product Code
HXS
Twister, Wire
1
Product Code
HXW
Bender
1
Product Code
HXX
Screwdriver
1
Product Code
HXY
Brace, Drill
1
Product Code
HXZ
Cutter, Wire
1
Product Code
JDX
Instrument, Surgical, Sonic And Accessory/Attachment
2
Product Code
JDY
Evacuator, Vapor, Cement Monomer
1
Product Code
JDZ
Mixer, Cement, For Clinical Use
1
Product Code
KIH
Dispenser, Cement
1
Product Code
KII
Tube, Cement Ventilation
1
Product Code
KIL
Positioner, Socket
1
Product Code
KQZ
Component, Traction, Non-Invasive
1
Product Code
KTZ
Caliper
1
Product Code
LGF
Component, Cast
1
Product Code
LGG
Instrument, Cast Application/Removal, Manual
1
Product Code
LGH
Instrument, Cast Removal, Ac-Powered
1
Product Code
LXH
Orthopedic Manual Surgical Instrument
1
Product Code
LYQ
Accessories, Fixation, Spinal Intervertebral Body
1
Product Code
LYS
Bone Mill
1
Product Code
LZV
System, Cement Removal Extraction
2
Product Code
OAR
Injector, Vertebroplasty (Does Not Contain Cement)
1
Product Code
OCJ
Spinal Channeling Instrument, Vertebroplasty
1
Product Code
QBO
Instruments Designed For Press-Fit Osteochondral Implants
2
Product Code
HSZ
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
1
Product Code
HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
1
Product Code
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
1
Product Code
K
16
3308
SMARTO
1
Cleared 510(K)
K
11
2599
INSURGICAL SINGLE USE POWER EQUIPMENT
1
Cleared 510(K)
K
10
1563
SMARTO
1
Cleared 510(K)
K
97
2367
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
1
Cleared 510(K)
K
97
0378
STRYKER 2115 REPLACEMENT BATTERY (2115)
1
Cleared 510(K)
K
96
0711
ACUMED BONE GRAFT SYSTEM
1
Cleared 510(K)
K
95
1450
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
1
Cleared 510(K)
K
94
4488
S & S ORTHOPEDIC WIRE DRIVER 701
1
Cleared 510(K)
K
94
1285
ARTHREX GRAFT HARVESTING KIT
1
Cleared 510(K)
K
93
3101
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
1
Cleared 510(K)
K
93
3337
R AND D BATTERY REPLACEMENT
1
Cleared 510(K)
K
93
1395
SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
1
Cleared 510(K)
K
93
2307
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
1
Cleared 510(K)
K
88
4839
MODIFIED SAW BLADES TO THE SAGITAL SAW
1
Cleared 510(K)
K
87
3766
STERNAL POWER AWL
1
Cleared 510(K)
K
86
4137
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
1
Cleared 510(K)
K
85
0789
FLUTED SUCTION MENISCAL CUTTER
1
Cleared 510(K)
K
84
4162
EZ 505
1
Cleared 510(K)
K
84
4163
EZ 502
1
Cleared 510(K)
K
82
2790
MICRO-CRAFT OSCILLATING SAW HANDPIECE
1
Cleared 510(K)
K
82
0367
INTRA-ARTICULAR SURGICAL SYSTEM
1
Cleared 510(K)
K
80
0315
DUAL MPC CHARGER
1
Cleared 510(K)
K
80
0314
POWER PACK
1
Cleared 510(K)
K
80
0313
SAGITTAL SAW
1
Cleared 510(K)
K
80
0312
150 DRIVER/REAMER
1
Cleared 510(K)
K
80
0311
450 DRILL/800 DRILL
1
Cleared 510(K)
K
79
0063
DRILL, CORDLESS SURGICAL
1
Cleared 510(K)
K
78
0645
HMD-2000 BATTERY-POWERED MINI-DRILL, THE
1
Cleared 510(K)
K
77
1218
INTRA-ARTICULAR SHAVER
1
Cleared 510(K)
LXI
Guide, Drill, Ligament
1
Product Code
OJH
Orthopedic Tray
1
Product Code
PPP
Disposable Joint Aspiration/Injection Kit
1
Product Code
SAM
Battery-Powered Instruments Charged Through Sterile Barriers
1
Product Code
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 23 May 2025 at 11:06 pm
OR
/
subpart-e—surgical-devices
/
KIJ
/
K844163
View Source
EZ 502
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844163
510(k) Type
Traditional
Applicant
AEG POWER TOOL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/1985
Days to Decision
138 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
HSR
Unit, Traction, Hip, Non-Powered, Non-Penetrating
HRR
Scissors, Orthopedic, Surgical
HRT
Stripper, Surgical
HSP
Splint, Traction
HSQ
Belt, Pelvic, Traction
HTH
Protractor
HTJ
Gauge, Depth
HTO
Reamer
HTP
File
HTQ
Broach
HTS
Knife, Orthopedic
HTT
Burr, Orthopedic
HTW
Bit, Drill
HTX
Rongeur
HWA
Impactor
HWB
Extractor
HWD
Starter, Bone Screw
HWI
Corkscrew
HWJ
Awl
HWK
Trephine
HWL
Set, Hollow Mill
HWN
Instrument, Compression
HWO
Skid, Bone
HWP
Punch, Femoral Neck
HWQ
Passer
HWR
Driver, Prosthesis
HWT
Template
HWW
Countersink
HWX
Tap, Bone
HXB
Probe
HXC
Wrench
HXE
Fork
HXG
Tamp
HXI
Passer, Wire, Orthopedic
HXJ
Staple Driver
HXK
Holder, Needle; Orthopedic
HXN
Applier, Cerclage
HXO
Pusher, Socket
HXP
Instrument, Bending Or Contouring
HXQ
Crimper, Pin
HXS
Twister, Wire
HXW
Bender
HXX
Screwdriver
HXY
Brace, Drill
HXZ
Cutter, Wire
JDX
Instrument, Surgical, Sonic And Accessory/Attachment
JDY
Evacuator, Vapor, Cement Monomer
JDZ
Mixer, Cement, For Clinical Use
KIH
Dispenser, Cement
KII
Tube, Cement Ventilation
KIL
Positioner, Socket
KQZ
Component, Traction, Non-Invasive
KTZ
Caliper
LGF
Component, Cast
LGG
Instrument, Cast Application/Removal, Manual
LGH
Instrument, Cast Removal, Ac-Powered
LXH
Orthopedic Manual Surgical Instrument
LYQ
Accessories, Fixation, Spinal Intervertebral Body
LYS
Bone Mill
LZV
System, Cement Removal Extraction
OAR
Injector, Vertebroplasty (Does Not Contain Cement)
OCJ
Spinal Channeling Instrument, Vertebroplasty
QBO
Instruments Designed For Press-Fit Osteochondral Implants
HSZ
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
K
16
3308
SMARTO
K
11
2599
INSURGICAL SINGLE USE POWER EQUIPMENT
K
10
1563
SMARTO
K
97
2367
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K
97
0378
STRYKER 2115 REPLACEMENT BATTERY (2115)
K
96
0711
ACUMED BONE GRAFT SYSTEM
K
95
1450
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
K
94
4488
S & S ORTHOPEDIC WIRE DRIVER 701
K
94
1285
ARTHREX GRAFT HARVESTING KIT
K
93
3101
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K
93
3337
R AND D BATTERY REPLACEMENT
K
93
1395
SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
K
93
2307
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K
88
4839
MODIFIED SAW BLADES TO THE SAGITAL SAW
K
87
3766
STERNAL POWER AWL
K
86
4137
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K
85
0789
FLUTED SUCTION MENISCAL CUTTER
K
84
4162
EZ 505
K
84
4163
EZ 502
K
82
2790
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K
82
0367
INTRA-ARTICULAR SURGICAL SYSTEM
K
80
0315
DUAL MPC CHARGER
K
80
0314
POWER PACK
K
80
0313
SAGITTAL SAW
K
80
0312
150 DRIVER/REAMER
K
80
0311
450 DRILL/800 DRILL
K
79
0063
DRILL, CORDLESS SURGICAL
K
78
0645
HMD-2000 BATTERY-POWERED MINI-DRILL, THE
K
77
1218
INTRA-ARTICULAR SHAVER
LXI
Guide, Drill, Ligament
OJH
Orthopedic Tray
PPP
Disposable Joint Aspiration/Injection Kit
SAM
Battery-Powered Instruments Charged Through Sterile Barriers
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-e—surgical-devices
/
KIJ
/
K844163
View Source
EZ 502
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844163
510(k) Type
Traditional
Applicant
AEG POWER TOOL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/1985
Days to Decision
138 days