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
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
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
K
14
3191
IntelliSense Drill
1
Cleared 510(K)
K
10
2743
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
1
Cleared 510(K)
K
06
3688
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
1
Cleared 510(K)
K
05
0766
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
1
Cleared 510(K)
K
04
3310
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
1
Cleared 510(K)
K
02
2744
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
1
Cleared 510(K)
K
01
2676
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
1
Cleared 510(K)
K
01
2694
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
1
Cleared 510(K)
K
99
0816
AVCORE SYSTEM
1
Cleared 510(K)
K
97
3736
AESCULAP HILAN MOTOR SYSTEM
1
Cleared 510(K)
K
97
3560
BONE GRAFT HARVESTER
1
Cleared 510(K)
K
97
2508
SURGICAL BURS AND SURGICAL DRILL BITS
1
Cleared 510(K)
K
97
1342
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
1
Cleared 510(K)
K
97
1544
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
1
Cleared 510(K)
K
96
2087
SERVOTRONIC EC100 SYSTEM
1
Cleared 510(K)
K
97
0088
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
1
Cleared 510(K)
K
97
0040
SPINE-TECH BONE HARVESTER
1
Cleared 510(K)
K
97
0023
MEDNEXT SURGICAL BUR
1
Cleared 510(K)
K
96
2913
SYNTHES STERILE DRILL BITS
1
Cleared 510(K)
K
96
2800
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
1
Cleared 510(K)
K
96
2215
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
1
Cleared 510(K)
K
96
2022
POWERCUT GOLD SURGICAL SYSTEM
1
Cleared 510(K)
K
96
1970
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
1
Cleared 510(K)
K
96
1759
CEMENT AND BONE REMOVAL KIT
1
Cleared 510(K)
K
96
0720
EXACTECH STERILE MODULAR DRILL BIT
1
Cleared 510(K)
K
96
0852
HALL MODULAR ACETABULAR REAMER SYSTEM
1
Cleared 510(K)
K
95
3968
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
1
Cleared 510(K)
K
95
5098
3M MINI-DRIVER ELECTRIC SYSTEM
1
Cleared 510(K)
K
95
5591
MICROAIRE SMARTDRIVE SYSTEM
1
Cleared 510(K)
K
95
2543
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET
1
Cleared 510(K)
K
95
0013
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
1
Cleared 510(K)
K
94
6197
CONSENSUS(TM) PATELLA REAMER
1
Cleared 510(K)
K
94
4946
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
1
Cleared 510(K)
K
94
5208
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
1
Cleared 510(K)
K
94
5189
CONSENSUS HIP SYSTEM -- CALCAR PLANER
1
Cleared 510(K)
K
94
5186
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
1
Cleared 510(K)
K
94
3589
STRYKER TOTAL PERFORMANCE SYSTEM
1
Cleared 510(K)
K
94
2108
COHORT BONE BRUSH
1
Cleared 510(K)
K
94
2956
SURGICAL INSTRUMENTS AND ACCESSORIES
1
Cleared 510(K)
K
94
2660
HALL MICROCHOICE ELECTRIC POWERED SYSTEM
1
Cleared 510(K)
K
93
2918
TOTAL KNEE KIT
1
Cleared 510(K)
K
93
1429
COOL CUT
1
Cleared 510(K)
K
93
5753
THE GRAFTOLOGER
1
Cleared 510(K)
K
93
1734
INTERMEDICS ORTHOPEDICS DRILL BITS
1
Cleared 510(K)
K
93
5322
SNAP BONE REAMER
1
Cleared 510(K)
K
93
5516
SNAP DRILL
1
Cleared 510(K)
K
93
1176
BONE SAW BLADES
1
Cleared 510(K)
K
93
2699
ARTHREX AR-8200 SHAVER SYSTEM
1
Cleared 510(K)
K
93
5567
SODEM POWER SYSTEM
1
Cleared 510(K)
K
93
2261
ES-100 ACCESSORIES
1
Cleared 510(K)
K
93
1837
ACUFEX STERILE DRILLS
1
Cleared 510(K)
K
93
0363
POWERED SURGICAL INSTRUMENT ACCESSORY
1
Cleared 510(K)
K
93
0319
OSTEON ADAPTOR/CRADLE
1
Cleared 510(K)
K
92
2056
HHI ELECTRIC CONSOLE #875-000
1
Cleared 510(K)
K
92
1131
CKS OSCILLATING SAW BLADE
1
Cleared 510(K)
K
91
1930
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
1
Cleared 510(K)
K
91
1929
SMALL BONE FIXATION SYSTEM
1
Cleared 510(K)
K
90
2525
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
1
Cleared 510(K)
K
90
3650
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
1
Cleared 510(K)
K
90
2447
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
1
Cleared 510(K)
K
90
2332
HALL MODULAR ACETABULAR REAMER SYSTEM
1
Cleared 510(K)
K
90
1165
MODULAR FLEXIBLE DRILLING SYSTEM
1
Cleared 510(K)
K
89
5198
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
1
Cleared 510(K)
K
88
2008
ACE SCREW REMOVAL TREPHINE
1
Cleared 510(K)
K
88
0150
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
1
Cleared 510(K)
K
87
4044
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
1
Cleared 510(K)
K
87
1717
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
1
Cleared 510(K)
K
86
4929
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
1
Cleared 510(K)
K
85
5216
3M ARTHROSCOPIC SURGICAL SYSTEM
1
Cleared 510(K)
K
85
4987
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
1
Cleared 510(K)
K
85
3376
MORGAN SUTURE-DRILL
1
Cleared 510(K)
K
85
3489
DEXTRA PRECISION POWER SYSTEM
1
Cleared 510(K)
K
83
3940
TORQUE PLUS CATALOG 30120
1
Cleared 510(K)
K
80
2105
C-BLADE
1
Cleared 510(K)
K
79
2353
INTRA-ARTICULATED EDGER-PLANER SYSTEM
1
Cleared 510(K)
K
76
0977
CHARNLEY FEMUR DRILL #1 AND #2
1
Cleared 510(K)
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
1
Product Code
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 9 May 2025 at 11:05 pm
OR
/
subpart-e—surgical-devices
/
HWE
/
K903650
View Source
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903650
510(k) Type
Traditional
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/14/1990
Days to Decision
32 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
K
14
3191
IntelliSense Drill
K
10
2743
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
K
06
3688
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K
05
0766
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
K
04
3310
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K
02
2744
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K
01
2676
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
K
01
2694
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K
99
0816
AVCORE SYSTEM
K
97
3736
AESCULAP HILAN MOTOR SYSTEM
K
97
3560
BONE GRAFT HARVESTER
K
97
2508
SURGICAL BURS AND SURGICAL DRILL BITS
K
97
1342
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K
97
1544
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K
96
2087
SERVOTRONIC EC100 SYSTEM
K
97
0088
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K
97
0040
SPINE-TECH BONE HARVESTER
K
97
0023
MEDNEXT SURGICAL BUR
K
96
2913
SYNTHES STERILE DRILL BITS
K
96
2800
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
K
96
2215
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K
96
2022
POWERCUT GOLD SURGICAL SYSTEM
K
96
1970
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K
96
1759
CEMENT AND BONE REMOVAL KIT
K
96
0720
EXACTECH STERILE MODULAR DRILL BIT
K
96
0852
HALL MODULAR ACETABULAR REAMER SYSTEM
K
95
3968
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K
95
5098
3M MINI-DRIVER ELECTRIC SYSTEM
K
95
5591
MICROAIRE SMARTDRIVE SYSTEM
K
95
2543
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET
K
95
0013
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K
94
6197
CONSENSUS(TM) PATELLA REAMER
K
94
4946
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K
94
5208
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K
94
5189
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K
94
5186
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K
94
3589
STRYKER TOTAL PERFORMANCE SYSTEM
K
94
2108
COHORT BONE BRUSH
K
94
2956
SURGICAL INSTRUMENTS AND ACCESSORIES
K
94
2660
HALL MICROCHOICE ELECTRIC POWERED SYSTEM
K
93
2918
TOTAL KNEE KIT
K
93
1429
COOL CUT
K
93
5753
THE GRAFTOLOGER
K
93
1734
INTERMEDICS ORTHOPEDICS DRILL BITS
K
93
5322
SNAP BONE REAMER
K
93
5516
SNAP DRILL
K
93
1176
BONE SAW BLADES
K
93
2699
ARTHREX AR-8200 SHAVER SYSTEM
K
93
5567
SODEM POWER SYSTEM
K
93
2261
ES-100 ACCESSORIES
K
93
1837
ACUFEX STERILE DRILLS
K
93
0363
POWERED SURGICAL INSTRUMENT ACCESSORY
K
93
0319
OSTEON ADAPTOR/CRADLE
K
92
2056
HHI ELECTRIC CONSOLE #875-000
K
92
1131
CKS OSCILLATING SAW BLADE
K
91
1930
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
K
91
1929
SMALL BONE FIXATION SYSTEM
K
90
2525
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K
90
3650
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K
90
2447
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
K
90
2332
HALL MODULAR ACETABULAR REAMER SYSTEM
K
90
1165
MODULAR FLEXIBLE DRILLING SYSTEM
K
89
5198
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K
88
2008
ACE SCREW REMOVAL TREPHINE
K
88
0150
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K
87
4044
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K
87
1717
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K
86
4929
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
K
85
5216
3M ARTHROSCOPIC SURGICAL SYSTEM
K
85
4987
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K
85
3376
MORGAN SUTURE-DRILL
K
85
3489
DEXTRA PRECISION POWER SYSTEM
K
83
3940
TORQUE PLUS CATALOG 30120
K
80
2105
C-BLADE
K
79
2353
INTRA-ARTICULATED EDGER-PLANER SYSTEM
K
76
0977
CHARNLEY FEMUR DRILL #1 AND #2
KIJ
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
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
/
HWE
/
K903650
View Source
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903650
510(k) Type
Traditional
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/14/1990
Days to Decision
32 days