Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- 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
- 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
- K991588EMS SWISS ORTHOCLAST1Cleared 510(K)
- K972860CURVTEK TSR SYSTEM1Cleared 510(K)
- K970345ALIGNMENT INSTRUMENT1Cleared 510(K)
- K955084ASPACH 65,000 (MODIFICATION)1Cleared 510(K)
- K954080SODEM HIGH SPEED SYSTEM1Cleared 510(K)
- K944590ETHICON DRILL BIT AND DRILL GUIDE1Cleared 510(K)
- K934336SPINALPLANE1Cleared 510(K)
- K940276FILTER, DIFFUSER1Cleared 510(K)
- K942760PNEUMATIC WIRE TENSIONER1Cleared 510(K)
- K941681ARTHREX CIRCULAR HARVESTING SAW1Cleared 510(K)
- K935367TAVA WIRE-DRIVER1Cleared 510(K)
- K934431PNEUMATIC WIRE TENSIONER1Cleared 510(K)
- K930785THE DE SOUTTER M182 DRILL1Cleared 510(K)
- K930784THE DE SOUTTER M193 REAMER1Cleared 510(K)
- K926547MEDNEXT 1000 BONE DISSECTING SYSTEM1Cleared 510(K)
- K922661HHI PNEUMATIC ROTARY DRILL1Cleared 510(K)
- K915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE1Cleared 510(K)
- K914845M170 PNEUMATICALLY OPERATED OSCILLATING SAW1Cleared 510(K)
- K913629JOHNSON AND JOHNSON POWER SYSTEM1Cleared 510(K)
- K913559OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR1Cleared 510(K)
- K905027CUP OUT1Cleared 510(K)
- K905277MICRO-AIRE 4220-000 OSCILLATING SAW1Cleared 510(K)
- K905187BONE RASPS1Cleared 510(K)
- K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS1Cleared 510(K)
- K903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-2291Cleared 510(K)
- K901455THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM1Cleared 510(K)
- K900210BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 25001Cleared 510(K)
- K885229MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS1Cleared 510(K)
- K895121INTERMEDICS POWER BROACH IMPACTOR1Cleared 510(K)
- K885273MICRO SURGICAL INSTRUMENT SYSTEM1Cleared 510(K)
- K884492MICRO SURGICAL INSTRUMENT SYSTEM1Cleared 510(K)
- K881954CONCEPT POWER SYSTEM1Cleared 510(K)
- K880881ARTUS DISPOSABLE SHEATHS/CUTTERS1Cleared 510(K)
- K881250ACE PNEUMATIC OSCILLATING SAW1Cleared 510(K)
- K880074RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS1Cleared 510(K)
- K880324MICRO-AIRE CEMENT REMOVAL TOOLS1Cleared 510(K)
- K8725501.1 COUPLERS AND 1.2 ADAPTERS1Cleared 510(K)
- K871891KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER1Cleared 510(K)
- K871287ORTHOPEDIC DRILL GUIDE1Cleared 510(K)
- K864314EFTEKHAR RECHANNELIZATION DRILL GUIDE1Cleared 510(K)
- K861405REPLACEMENT HOSES1Cleared 510(K)
- K851443MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER1Cleared 510(K)
- K844130ACUFEX ARTHROSCOPIC SHAVER1Cleared 510(K)
- K844131NUCLEOTOME1Cleared 510(K)
- K840831ENDOTOME PNEUMATIC ORTHOPAEDIC CUT1Cleared 510(K)
- K831756ANSPACH 65,0001Cleared 510(K)
- K811834MICRO OSCILLATING SAW1Cleared 510(K)
- K811005CORB TM COUNTERROTATING BIOPSY NEEDLE1Cleared 510(K)
- K803284OSTEO OSCILAIR1Cleared 510(K)
- K801329ANSPACH INSTRUMENT CADDY1Cleared 510(K)
- K800275CEBOTOME DRILL1Cleared 510(K)
- K7910563M CEMENT REMOVER1Cleared 510(K)
- K790645ENDOTOME1Cleared 510(K)
- K781979SURGAIRTOME TWO1Cleared 510(K)
- K780139PNEUMATIC POWERED BUR1Cleared 510(K)
- K772324WIREDRIVER1Cleared 510(K)
- 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
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K885229
- 510(k) Type
- Traditional
- Applicant
- ROMANO SURGICAL INSTRUMENTATION, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/29/1989
- Days to Decision
- 294 days