Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- 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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- K240567CustomizedBone Service2Cleared 510(K)
- K231920Longeviti ClearFit OTS Cranial Implant2Cleared 510(K)
- K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)2Cleared 510(K)
- K220357MedCAD AccuShape Titanium Patient-Specific Cranial Implant2Cleared 510(K)
- K210099Meticuly Patient-Specific Titanium Mesh Implant2Cleared 510(K)
- K212058Longeviti ClearFit™ OTS Cranial Implants2Cleared 510(K)
- K210616Longeviti PMMA Static Cranial Implant2Cleared 510(K)
- K203349Longeviti ClearFit Cranial Implant2Cleared 510(K)
- K202901Longeviti ClearFit Cranial Implant2Cleared 510(K)
- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional2Cleared 510(K)
- K193547CustomizedBone Service2Cleared 510(K)
- K191210Longeviti ClearFit Cranial Implant2Cleared 510(K)
- K180064OsteoFab Patient Specific Cranial Device2Cleared 510(K)
- K180513CustomizedBone Service2Cleared 510(K)
- K170410Longeviti PMMA Static Cranial Implant2Cleared 510(K)
- K171507CustomizedBone Service2Cleared 510(K)
- K161090Cranial PSI2Cleared 510(K)
- K160707CustomizedBone Service2Cleared 510(K)
- K151692BioArchitects Patient Specific Cranial/Craniofacial Plate2Cleared 510(K)
- K151382Patient Contoured Implant-PEEK (PCI-PEEK)2Cleared 510(K)
- K130447SPEEDY FLAP SYSTEM2Cleared 510(K)
- K133082OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE2Cleared 510(K)
- K121818OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE2Cleared 510(K)
- K121755CUSTOM CRANIOFACIAL IMPLANT (CCI)2Cleared 510(K)
- K122353CRAINFIX 2 TITANIUM CLAMP SYSTEM2Cleared 510(K)
- K121102OSTEOSYMBIONICS PEEK CRANIAL IMPLANT2Cleared 510(K)
- K110684MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT2Cleared 510(K)
- K103582KELYNIAM CUSTOM SKULL IMPLANT (CSI)2Cleared 510(K)
- K082175MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION2Cleared 510(K)
- K072707PATIENT CONTOURED MESH-PEEK (PCM-P)2Cleared 510(K)
- K070901MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K062819BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K062857KLS MARTIN QUICK DISC2Cleared 510(K)
- K062570PATIENT CONTOURED MESH (PCM)2Cleared 510(K)
- K052871STRYKER CUSTOM TI IMPLANT2Cleared 510(K)
- K053199SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT2Cleared 510(K)
- K033868SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS2Cleared 510(K)
- K040864CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM2Cleared 510(K)
- K031034SPIN DOWN RAPIDFLAP2Cleared 510(K)
- K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEM2Cleared 510(K)
- K030378STRYKER LEIBINGER CRANIAL FIXATION SYSTEM2Cleared 510(K)
- K020088MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K013050THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K013000MEDTRONIC INVISX BURR HOLE LOCK, MODEL 605202Cleared 510(K)
- K993990LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM2Cleared 510(K)
- K992000SYNTHES CRANIAL FLAP TUBE CLAMP2Cleared 510(K)
- K991860SYNTHES CRANIAL FLAP TWIST CLAMP2Cleared 510(K)
- K991029RAPIDFLAP CRANIAL CLAMP2Cleared 510(K)
- K971252SEVRAIN CRANIAL CLAMP2Cleared 510(K)
- K971408SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)2Cleared 510(K)
- K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM2Cleared 510(K)
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- SENBiofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety2Product Code
- 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
OsteoFab Patient Specific Cranial Device
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180064
- 510(k) Type
- Traditional
- Applicant
- Oxford Performance Materials, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/27/2018
- Days to Decision
- 199 days
- Submission Type
- Summary