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
- HBDHandpiece (Brace), Drill1Product Code
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2Product Code
- K250815Hubly Drill (H100)2Cleared 510(K)
- K252060GREEN2Cleared 510(K)
- K252662UniBur2Cleared 510(K)
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)2Cleared 510(K)
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)2Cleared 510(K)
- K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R2Cleared 510(K)
- K232684Surgify Halo2Cleared 510(K)
- K230619Hubly Electric Drill (H100)2Cleared 510(K)
- K2231992.1 x 255mm Drill, 22mm Stop2Cleared 510(K)
- K2130722.1 x 255mm Drill, 22mm Stop2Cleared 510(K)
- K213208Twist Drills2Cleared 510(K)
- K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm2Cleared 510(K)
- K202120P300 Attachment2Cleared 510(K)
- K203739ELAN 4 Electro Motor System2Cleared 510(K)
- K210377Stryker iBur hubs and cutting accessories2Cleared 510(K)
- K191479Velocity Alpha Highspeed Surgical Drill System2Cleared 510(K)
- K183203ELAN 4 Tools2Cleared 510(K)
- K183545Anspach Helix Dissection Tools2Cleared 510(K)
- K191049Stryker MIS and Footed Attachments2Cleared 510(K)
- K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2Cleared 510(K)
- K182527ELAN 4 Tools2Cleared 510(K)
- K172709ELAN 4 Electro Motor System Tools2Cleared 510(K)
- K182436POWEREASE System2Cleared 510(K)
- K170442Cranial Drill Bits and Accessories2Cleared 510(K)
- K162542OsteoMed PINNACLE Driver2Cleared 510(K)
- K161704Phasor Drill2Cleared 510(K)
- K153519DReal2Cleared 510(K)
- K143399Stryker Footed Attachments and Cutting Accessories2Cleared 510(K)
- K143540Stryker MIS Attachments and Cutting Accessories2Cleared 510(K)
- K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2Cleared 510(K)
- K130755HICUT HIGHSPEED INSTRUMENT2Cleared 510(K)
- K132436VARIOGUIDE DRILL KIT2Cleared 510(K)
- K123270POWEREASE SYSTEM2Cleared 510(K)
- K121264TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE2Cleared 510(K)
- K113476ANSPACH DISSECTION TOOLS2Cleared 510(K)
- K111520IPC POWEREASE SYSTEM2Cleared 510(K)
- K081475ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]2Cleared 510(K)
- K080802EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL2Cleared 510(K)
- K072315MIDAS REX CURVED BUR2Cleared 510(K)
- K070876STRYKER TWIST DRILLS2Cleared 510(K)
- K062842TWIST DRILL2Cleared 510(K)
- K050628ANSPACH COUPLER2Cleared 510(K)
- K042783ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM2Cleared 510(K)
- K040076ANSPACH ADVANCED MICRO SAW ATTACHMENTS2Cleared 510(K)
- K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM2Cleared 510(K)
- K030172SMALL HIGH SPEED MOTOR DRILL SYSTEM2Cleared 510(K)
- K022942CRANIOCUT2Cleared 510(K)
- K014060MICROAIRE 1000E SYSTEM2Cleared 510(K)
- K002903ANSPACH ANGLED MICRONOSE ATTACHMENT2Cleared 510(K)
- K984035XK-95 HIGH SPEED MOTOR DRILL SYSTEM2Cleared 510(K)
- K94354175K STAIGHT DRILL2Cleared 510(K)
- K935861MEDNEXT BUR2Cleared 510(K)
- K930229CLINICAL NEURO SYSTEMS CRANIAL DRILL2Cleared 510(K)
- K922299ZEPPELIN MOTOR DRILL SYSTEM2Cleared 510(K)
- K911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED2Cleared 510(K)
- K911812ACRA-CUT WIRE PASS DRILL2Cleared 510(K)
- K905097MICRO-AIRE MODEL NUMBER: MK-4262Cleared 510(K)
- K902703CRANIOTOME BLADE OR DRILL BIT2Cleared 510(K)
- K903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL2Cleared 510(K)
- K900388MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES2Cleared 510(K)
- K881418CRANIOTOME BLADE OR NEURO BLADE2Cleared 510(K)
- K880601WIRE PASS DRILL BITS2Cleared 510(K)
- K875224HUDSON CRANINAL BURRS2Cleared 510(K)
- K873692RAYLOR(TM) DRILL STOP2Cleared 510(K)
- 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
POWEREASE System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K182436
- 510(k) Type
- Special
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/4/2018
- Days to Decision
- 27 days
- Submission Type
- Summary