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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- GXDGenerator, Lesion, Radiofrequency2Product Code
- GXELeukotome1Product Code
- GXHDevice, Surgical, Cryogenic2Product Code
- GXIProbe, Radiofrequency Lesion2Product Code
- GXJPunch, Skull1Product Code
- GXLScrewdriver, Skullplate1Product Code
- GXMAnvil, Skull Plate1Product Code
- GYKInstrument, Shunt System Implantation1Product Code
- GZQInstrument, Dowel Cutting2Product Code
- GZTRetractor, Self-Retaining, For Neurosurgery2Product Code
- GZXInstrument, Microsurgical1Product Code
- HADRongeur, Powered2Product Code
- HAERongeur, Manual2Product Code
- HAOInstrument, Surgical, Non-Powered1Product Code
- HASNeedle, Neurosurgical Suture1Product Code
- HAWNeurological Stereotaxic Instrument2Product Code
- HBANeurosurgical Paddie2Product Code
- HBBMotor, Drill, Pneumatic2Product Code
- HBCMotor, Drill, Electric2Product Code
- K233153Traus SSG10 Surgical System2Cleared 510(K)
- K232938Traus SSG30 Surgical System2Cleared 510(K)
- K213697ORiGO System2Cleared 510(K)
- K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)2Cleared 510(K)
- K193630hekaDrill2Cleared 510(K)
- K183515MR8 Drill System, Midas Rex MR8 ClearView Tools2Cleared 510(K)
- K173066OSSEODUO Shaver and Drill System2Cleared 510(K)
- K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools2Cleared 510(K)
- K163565MR8 Drill System2Cleared 510(K)
- K152960ELAN 4 Motor System2Cleared 510(K)
- K133604ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS2Cleared 510(K)
- K132264PRIMADO2 TOTAL SURGICAL SYSTEM2Cleared 510(K)
- K130497D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION2Cleared 510(K)
- K083112PRIMADO2Cleared 510(K)
- K080444CONMED LINVATEC OSPREY DRILL SYSTEM2Cleared 510(K)
- K060260MICROPOWER HAND PIECE HIGH SPEED DRILL2Cleared 510(K)
- K053526MICROSPEED UNI MOTOR SYSTEM2Cleared 510(K)
- K022986THE BIOPLATE BATTERY POWERED DRILL2Cleared 510(K)
- K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)2Cleared 510(K)
- K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)2Cleared 510(K)
- K011444ANSPACH EMAX DRILL SYSTEM2Cleared 510(K)
- K003612MICROSPEED EC MOTORSYSTEM GD650/GD6532Cleared 510(K)
- K002523ADVANTAGE DRIVE SYSTEM2Cleared 510(K)
- K972857SERVOTRONIC EC100 SYSTEM2Cleared 510(K)
- K862989SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE2Cleared 510(K)
- K812436450/800 DRILL2Cleared 510(K)
- HBDHandpiece (Brace), Drill1Product Code
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2Product Code
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)2Product Code
- HBGDrills, Burrs, Trephines & Accessories (Manual)2Product Code
- HBLHolder, Head, Neurosurgical (Skull Clamp)2Product Code
- HBMHeadrest, Neurosurgical1Product Code
- HBNChair, Neurosurgical1Product Code
- HBOClip, Scalp2Product Code
- HBQInstrument, Clip Removal1Product Code
- HBRRack, Clip1Product Code
- HBSInstrument, Clip Forming/Cutting1Product Code
- HBXInstrument, Cranioplasty Material Forming1Product Code
- HCACatheter, Ventricular2Product Code
- HCDCannula, Ventricular1Product Code
- HCIApplier, Aneurysm Clip2Product Code
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)2Product Code
- NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed2Product Code
- NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed2Product Code
- NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed2Product Code
- NMNInstrument, Clip, Forming/Cutting, Reprocessed1Product Code
- OJGNeurological Tray1Product Code
- ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri2Product Code
- PIYStainless Steel Instrument, Shunt System Implantation1Product Code
- PPTCranial Surgical Planning And Instrument Guides2Product Code
- PVMEndoscopic Ventricular Catheter Placement Kit2Product Code
- QFXDiagnostic Neurosurgical Microscope Filter2Product Code
- QRISurgical Planning Software For Neurological Stereotaxic Instruments2Product Code
- SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PRIMADO
- Page Type
- Cleared 510(K)
- 510(k) Number
- K083112
- 510(k) Type
- Traditional
- Applicant
- NAKANISHI, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/2009
- Days to Decision
- 190 days
- Submission Type
- Summary