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
- 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
- K241027Permatage Settable Bone Putty2Cleared 510(K)
- K232771Montage Flowable Settable, Resorbable Bone Paste2Cleared 510(K)
- K231475MONTAGE-QS Settable, Resorbable Bone Putty2Cleared 510(K)
- K221933MONTAGE Settable, Resorbable Bone Putty2Cleared 510(K)
- K182742DB-CMF2Cleared 510(K)
- K162864OsteoVation Impact2Cleared 510(K)
- K143661DirectInject2Cleared 510(K)
- K102018NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY2Cleared 510(K)
- K091382KRYPTONITE BONE CEMENT2Cleared 510(K)
- K070012POLYBONE2Cleared 510(K)
- K072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT2Cleared 510(K)
- K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-12802Cleared 510(K)
- K060763STRYKER INJECTABLE CEMENT2Cleared 510(K)
- K060445NORIAN CRS BONE CEMENT2Cleared 510(K)
- K060443NORIAN CRS FAST SET PUTTY2Cleared 510(K)
- K051093OSTEOPORE PCL SCAFFOLD2Cleared 510(K)
- K051784OSTEOVATION CMF BONE VOID FILLER2Cleared 510(K)
- K043334BONE SOURCE HAC RAPID SETTING CEMENT2Cleared 510(K)
- K042414VISIOPLAST ACRYLIC RESIN2Cleared 510(K)
- K043280MIMIX MP BONE VOID FILLER2Cleared 510(K)
- K042072CALLOS CMF BONE VOID FILLER2Cleared 510(K)
- K041350SYNTHES (USA) CHRONOS2Cleared 510(K)
- K040152BONE CEMENT FOR CRANIOPLASTY2Cleared 510(K)
- K032366BONESOURCE HAC FAST SETTING CEMENT2Cleared 510(K)
- K032307CAP BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K011399BIOMET CRANIOFACIAL ACRYLIC CEMENT2Cleared 510(K)
- K023575CONCERT CRANIOPLAST2Cleared 510(K)
- K023718QUICKSET MIMIX BONE VOID FILLER2Cleared 510(K)
- K021440BONESOURCE HAC2Cleared 510(K)
- K012589FAST SET PUTTY2Cleared 510(K)
- K011736DRG QUICKMIX2Cleared 510(K)
- K012569MODIFICATION TO: INJECTABLE MIMIX2Cleared 510(K)
- K994022PARALLAX CRANIOSET2Cleared 510(K)
- K990290CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER2Cleared 510(K)
- K991398BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT2Cleared 510(K)
- K983009BSM- BONE SUBSTITUTE MATERIAL2Cleared 510(K)
- K982040MEDPOR SURGICAL GRANULE IMPLANTS2Cleared 510(K)
- K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC2Cleared 510(K)
- K964537BONESOURCE HYDROXYAPATITE CEMENT (HAC)2Cleared 510(K)
- K953339BONESOURCE HYDROXYAPATITE CEMENT (HAC)2Cleared 510(K)
- K873689CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL2Cleared 510(K)
- 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
- 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
- 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
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K072601
- 510(k) Type
- Traditional
- Applicant
- OSTEOSYMBIONICS, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/10/2007
- Days to Decision
- 87 days
- Submission Type
- Summary