Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating1Product Code
- HRRScissors, Orthopedic, Surgical1Product Code
- HRTStripper, Surgical1Product Code
- HSPSplint, Traction1Product Code
- HSQBelt, Pelvic, Traction1Product Code
- HTHProtractor1Product Code
- HTJGauge, Depth1Product Code
- HTOReamer1Product Code
- HTPFile1Product Code
- HTQBroach1Product Code
- HTSKnife, Orthopedic1Product Code
- HTTBurr, Orthopedic1Product Code
- HTWBit, Drill1Product Code
- HTXRongeur1Product Code
- HWAImpactor1Product Code
- HWBExtractor1Product Code
- HWDStarter, Bone Screw1Product Code
- HWICorkscrew1Product Code
- HWJAwl1Product Code
- HWKTrephine1Product Code
- HWLSet, Hollow Mill1Product Code
- HWNInstrument, Compression1Product Code
- HWOSkid, Bone1Product Code
- HWPPunch, Femoral Neck1Product Code
- HWQPasser1Product Code
- HWRDriver, Prosthesis1Product Code
- HWTTemplate1Product Code
- HWWCountersink1Product Code
- HWXTap, Bone1Product Code
- HXBProbe1Product Code
- HXCWrench1Product Code
- HXEFork1Product Code
- HXGTamp1Product Code
- HXIPasser, Wire, Orthopedic1Product Code
- HXJStaple Driver1Product Code
- HXKHolder, Needle; Orthopedic1Product Code
- HXNApplier, Cerclage1Product Code
- HXOPusher, Socket1Product Code
- HXPInstrument, Bending Or Contouring1Product Code
- HXQCrimper, Pin1Product Code
- HXSTwister, Wire1Product Code
- HXWBender1Product Code
- HXXScrewdriver1Product Code
- HXYBrace, Drill1Product Code
- HXZCutter, Wire1Product Code
- JDXInstrument, Surgical, Sonic And Accessory/Attachment2Product Code
- JDYEvacuator, Vapor, Cement Monomer1Product Code
- JDZMixer, Cement, For Clinical Use1Product Code
- KIHDispenser, Cement1Product Code
- KIITube, Cement Ventilation1Product Code
- KILPositioner, Socket1Product Code
- KQZComponent, Traction, Non-Invasive1Product Code
- KTZCaliper1Product Code
- LGFComponent, Cast1Product Code
- LGGInstrument, Cast Application/Removal, Manual1Product Code
- LGHInstrument, Cast Removal, Ac-Powered1Product Code
- LXHOrthopedic Manual Surgical Instrument1Product Code
- LYQAccessories, Fixation, Spinal Intervertebral Body1Product Code
- LYSBone Mill1Product Code
- LZVSystem, Cement Removal Extraction2Product Code
- OARInjector, Vertebroplasty (Does Not Contain Cement)1Product Code
- OCJSpinal Channeling Instrument, Vertebroplasty1Product Code
- QBOInstruments Designed For Press-Fit Osteochondral Implants2Product Code
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1Product Code
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1Product Code
- K143191IntelliSense Drill1Cleared 510(K)
- K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES1Cleared 510(K)
- K063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE1Cleared 510(K)
- K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM1Cleared 510(K)
- K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM1Cleared 510(K)
- K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS1Cleared 510(K)
- K012676REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS1Cleared 510(K)
- K012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS1Cleared 510(K)
- K990816AVCORE SYSTEM1Cleared 510(K)
- K973736AESCULAP HILAN MOTOR SYSTEM1Cleared 510(K)
- K973560BONE GRAFT HARVESTER1Cleared 510(K)
- K972508SURGICAL BURS AND SURGICAL DRILL BITS1Cleared 510(K)
- K971342DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)1Cleared 510(K)
- K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)1Cleared 510(K)
- K962087SERVOTRONIC EC100 SYSTEM1Cleared 510(K)
- K970088RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:1Cleared 510(K)
- K970040SPINE-TECH BONE HARVESTER1Cleared 510(K)
- K970023MEDNEXT SURGICAL BUR1Cleared 510(K)
- K962913SYNTHES STERILE DRILL BITS1Cleared 510(K)
- K962800STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES1Cleared 510(K)
- K962215CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER1Cleared 510(K)
- K962022POWERCUT GOLD SURGICAL SYSTEM1Cleared 510(K)
- K961970COMMAND 2 MICOELECTRIC SURGICAL SYSTEM1Cleared 510(K)
- K961759CEMENT AND BONE REMOVAL KIT1Cleared 510(K)
- K960720EXACTECH STERILE MODULAR DRILL BIT1Cleared 510(K)
- K960852HALL MODULAR ACETABULAR REAMER SYSTEM1Cleared 510(K)
- K953968AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)1Cleared 510(K)
- K9550983M MINI-DRIVER ELECTRIC SYSTEM1Cleared 510(K)
- K955591MICROAIRE SMARTDRIVE SYSTEM1Cleared 510(K)
- K952543GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET1Cleared 510(K)
- K950013CONSENSUS(TM) ORTHOPEDIC DRILL BIT1Cleared 510(K)
- K946197CONSENSUS(TM) PATELLA REAMER1Cleared 510(K)
- K944946CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER1Cleared 510(K)
- K945208CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER1Cleared 510(K)
- K945186CONSENUS HIP SYSTEM -- ACETABULAR REAMER1Cleared 510(K)
- K945189CONSENSUS HIP SYSTEM -- CALCAR PLANER1Cleared 510(K)
- K943589STRYKER TOTAL PERFORMANCE SYSTEM1Cleared 510(K)
- K942108COHORT BONE BRUSH1Cleared 510(K)
- K942956SURGICAL INSTRUMENTS AND ACCESSORIES1Cleared 510(K)
- K942660HALL MICROCHOICE ELECTRIC POWERED SYSTEM1Cleared 510(K)
- K932918TOTAL KNEE KIT1Cleared 510(K)
- K931429COOL CUT1Cleared 510(K)
- K935753THE GRAFTOLOGER1Cleared 510(K)
- K931734INTERMEDICS ORTHOPEDICS DRILL BITS1Cleared 510(K)
- K935322SNAP BONE REAMER1Cleared 510(K)
- K935516SNAP DRILL1Cleared 510(K)
- K931176BONE SAW BLADES1Cleared 510(K)
- K932699ARTHREX AR-8200 SHAVER SYSTEM1Cleared 510(K)
- K935567SODEM POWER SYSTEM1Cleared 510(K)
- K932261ES-100 ACCESSORIES1Cleared 510(K)
- K931837ACUFEX STERILE DRILLS1Cleared 510(K)
- K930363POWERED SURGICAL INSTRUMENT ACCESSORY1Cleared 510(K)
- K930319OSTEON ADAPTOR/CRADLE1Cleared 510(K)
- K922056HHI ELECTRIC CONSOLE #875-0001Cleared 510(K)
- K921131CKS OSCILLATING SAW BLADE1Cleared 510(K)
- K911930STERILE PACKAGED POWER INSTRUMENT ACCESSORIES1Cleared 510(K)
- K911929SMALL BONE FIXATION SYSTEM1Cleared 510(K)
- K902525ACE/WILLIAMS MICROSURGERY SAW SYSTEM1Cleared 510(K)
- K903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-3051Cleared 510(K)
- K902447CORING NEEDLE (TREPHINE, ORTHOPEDIC)1Cleared 510(K)
- K902332HALL MODULAR ACETABULAR REAMER SYSTEM1Cleared 510(K)
- K901165MODULAR FLEXIBLE DRILLING SYSTEM1Cleared 510(K)
- K895198HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM1Cleared 510(K)
- K882008ACE SCREW REMOVAL TREPHINE1Cleared 510(K)
- K880150PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM1Cleared 510(K)
- K874044INTRA-ARTICULAR ARTHROSCOPIC SHAVER1Cleared 510(K)
- K871717MODEL 28200C MICRO-ARTHROPLASTY SYSTEM1Cleared 510(K)
- K864929HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST1Cleared 510(K)
- K8552163M ARTHROSCOPIC SURGICAL SYSTEM1Cleared 510(K)
- K854987INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM1Cleared 510(K)
- K853376MORGAN SUTURE-DRILL1Cleared 510(K)
- K853489DEXTRA PRECISION POWER SYSTEM1Cleared 510(K)
- K833940TORQUE PLUS CATALOG 301201Cleared 510(K)
- K802105C-BLADE1Cleared 510(K)
- K792353INTRA-ARTICULATED EDGER-PLANER SYSTEM1Cleared 510(K)
- K760977CHARNLEY FEMUR DRILL #1 AND #21Cleared 510(K)
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment1Product Code
- LXIGuide, Drill, Ligament1Product Code
- OJHOrthopedic Tray1Product Code
- PPPDisposable Joint Aspiration/Injection Kit1Product Code
- SAMBattery-Powered Instruments Charged Through Sterile Barriers1Product Code
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MEDNEXT SURGICAL BUR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K970023
- 510(k) Type
- Traditional
- Applicant
- MEDNEXT, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/28/1997
- Days to Decision
- 56 days
- Submission Type
- Statement