Anesthesiology
Review Panel
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- ImmunologyReview Panel
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- OphthalmicReview Panel
- OrthopedicReview Panel
- 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
- K201274Ultrasonic Osteotomy Surgical System2Cleared 510(K)
- K172464XD880A Ultrasonic Osteotomy Surgical System2Cleared 510(K)
- K163610PIEZOTOME M+, PIEZOTOME M+ Handpiece2Cleared 510(K)
- K153743PIEZOSURGERY PLUS2Cleared 510(K)
- K132848PIEZOSURGERY FLEX2Cleared 510(K)
- K100410PIEZOELECTRIC SYSTEM2Cleared 510(K)
- K093805OSCAR 32Cleared 510(K)
- K083284PIEZOSURGERY MEDICAL2Cleared 510(K)
- K083830OSCAR BONE RESECTOR2Cleared 510(K)
- K072961LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)2Cleared 510(K)
- K051053OSCAR, MODEL OE3000DB2Cleared 510(K)
- K031280ULTRA-DRIVE 32Cleared 510(K)
- K022729VENTED CEMENT RESTRICTOR2Cleared 510(K)
- K002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL2Cleared 510(K)
- K961725OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION2Cleared 510(K)
- K930109KOMET MEDICAL SURGICAL POWER ACCESORIES2Cleared 510(K)
- K912931ITM SONIC SURGERY SYSTEM2Cleared 510(K)
- K911548ACRYL-X SYSTEM TM2Cleared 510(K)
- K905451SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE2Cleared 510(K)
- K900003SYSTEM TEN MODEL 100 SURGICAL SYSTEM2Cleared 510(K)
- K891408MODIFIED PROFILE HIP ACETABULAR PROSTHESIS2Cleared 510(K)
- K862504ACE MOS SAW AND THE ACE MOS SPINE SAW2Cleared 510(K)
- K800501PFIZER/AS&E 0450 LOCALIZER2Cleared 510(K)
- 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
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices2Product Code
- QLRManual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices2Product Code
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1Product Code
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1Product Code
- 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
ULTRA-DRIVE 3
- Page Type
- Cleared 510(K)
- 510(k) Number
- K031280
- 510(k) Type
- Traditional
- Applicant
- BIOMET, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/22/2003
- Days to Decision
- 153 days
- Submission Type
- Summary