Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- ImmunologyReview Panel
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- 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
- K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)2Cleared 510(K)
- K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)2Cleared 510(K)
- K202072MindsEye Expandable Port2Cleared 510(K)
- K180610Geister retractor for neuro - and spine surgery2Cleared 510(K)
- K172433NICO BrainPath2Cleared 510(K)
- K161680MEDICON Spinal Spreading Systems2Cleared 510(K)
- K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems2Cleared 510(K)
- K161004Self-retaining Retractor2Cleared 510(K)
- K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook2Cleared 510(K)
- K120691BRAIN PORT2Cleared 510(K)
- K113273SPOTLIGHT ACCESS SYSTEM2Cleared 510(K)
- K112913SPOTLIGHT ACCESS SYSTEM2Cleared 510(K)
- K093054SCALP DURA RETRACTOR, MODEL KS004742Cleared 510(K)
- K090272SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)2Cleared 510(K)
- K071771INSTRUMED RETRACTORS2Cleared 510(K)
- K071338FLEX ARM RETRACTOR SYSTEM2Cleared 510(K)
- K062814PIPELINE II ACCESS SYSTEM2Cleared 510(K)
- K060973VYCOR SURGICAL ACCESS SYSTEMS2Cleared 510(K)
- K060097GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-002Cleared 510(K)
- K050706HARMONY PORT SYSTEM, MODEL 1907 SERIES2Cleared 510(K)
- K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM2Cleared 510(K)
- K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM2Cleared 510(K)
- K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A10902Cleared 510(K)
- K945040HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR2Cleared 510(K)
- K935529CERVICAL SELF-RETAINING RETRACTOR2Cleared 510(K)
- K924876TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED2Cleared 510(K)
- K913233CODMAN LHALO SPLIT RING RETRACTOR SYSTEM2Cleared 510(K)
- K910621BLADES FOR SPINAL LAMINECTOMY RETRACTOR2Cleared 510(K)
- K905445ADSON-BECKMAN RETRACTOR, SPINAL2Cleared 510(K)
- K902517NEUROSURGICAL HEADFRAME ACCESSORIES2Cleared 510(K)
- K885120ESI MODEL MS-1032Cleared 510(K)
- K896156COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM2Cleared 510(K)
- K895395V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR2Cleared 510(K)
- K895537MODIFIED MEMORY RETRACTOR ARM2Cleared 510(K)
- K892543NEUROSURICAL RETRACTORS - VARIOUS TYPES2Cleared 510(K)
- K882071CRANK FRAME RETRACTOR2Cleared 510(K)
- K881160CRANK FRAME RETRACTOR2Cleared 510(K)
- K874829MEDCO MEMORY RETRACTOR SYSTEM2Cleared 510(K)
- K874956SELF-RETAINING RETRACTOR FOR NEUROSURGERY2Cleared 510(K)
- K873691CEDAR(TM) RETRACTOR RING2Cleared 510(K)
- K830332BUDDE-HALO RETRACTOR2Cleared 510(K)
- K801855CYCLOPAC TENS2Cleared 510(K)
- K801151DISPOSABLE SKIN RETRACTOR2Cleared 510(K)
- 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
- 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
PIPELINE II ACCESS SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K062814
- 510(k) Type
- Traditional
- Applicant
- DEPUY SPINE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/15/2006
- Days to Decision
- 86 days
- Submission Type
- Summary