Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- DZJDriver, Wire, And Bone Drill, Manual2Product Code
- DZKWire, Fixation, Intraosseous2Product Code
- DZLScrew, Fixation, Intraosseous2Product Code
- K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)2Cleared 510(K)
- K251569Bone Screw2Cleared 510(K)
- K243190USTOMED Bone Fixation/Bone Augmentation Systems - PIN2Cleared 510(K)
- K233419GBR System2Cleared 510(K)
- K240321MP Pin flat without thread (36BMP000020/MP20)2Cleared 510(K)
- K233721KLS Martin Drill-Free MMF Screw2Cleared 510(K)
- K231599Stryker MP, Mandible, HMMF and MMF AXS Screws2Cleared 510(K)
- K222367SAVE GBR2Cleared 510(K)
- K201210The Micro Screw System, Micro Screw System Basic2Cleared 510(K)
- K201561Membrane Screws and Membrane Tacks2Cleared 510(K)
- K182881Bone Screw, Bone Tack2Cleared 510(K)
- K181854OssBuilder System2Cleared 510(K)
- K171831Intra-Lock Bone Fixation System2Cleared 510(K)
- K161857Salvin Tenting Screw System2Cleared 510(K)
- K160991Neo GBR System2Cleared 510(K)
- K151540MC BIO Supertack Tack 3mm, 4mm and 5mm2Cleared 510(K)
- K151195OsteoMed IMF Screw2Cleared 510(K)
- K140908JUGGERKNOT MINI SOFT ANCHOR2Cleared 510(K)
- K132212DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL2Cleared 510(K)
- K130682MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT2Cleared 510(K)
- K103084NEODENT GRAFT SCREW2Cleared 510(K)
- K101902J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-0302Cleared 510(K)
- K100182SALVIN DENTAL SPECIALTIES FIXATION SCREW2Cleared 510(K)
- K093719PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#2Cleared 510(K)
- K093464RAPIDSORB PLUS SCREW SYSTEM2Cleared 510(K)
- K092855MILTEX MEMBRANE TACK KIT2Cleared 510(K)
- K083432DRILL FREE MMF SCREW2Cleared 510(K)
- K080430STOMA BONE BLOCK SCREW2Cleared 510(K)
- K073342SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW2Cleared 510(K)
- K063769ALPHA BIO BONE FIXATION SCREW SYSTEM2Cleared 510(K)
- K051871STOMA BONE SCREW2Cleared 510(K)
- K050606SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)2Cleared 510(K)
- K050515BONE BLOCK FIXATION SET2Cleared 510(K)
- K050535STRYKER MMF SCREW2Cleared 510(K)
- K042573KLS MARTIN DRILL-FREE MMF SCREW2Cleared 510(K)
- K041887SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS2Cleared 510(K)
- K031807SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS2Cleared 510(K)
- K022790THE AUTOTAC SYSTEM TITANIUM TACK2Cleared 510(K)
- K021850SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS2Cleared 510(K)
- K021522LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW2Cleared 510(K)
- K012486OSTEOMED BIORESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K012908BIOPLATE RESORBABLE BONE SCREW2Cleared 510(K)
- K011675THE AUTOTAC SYSTEM2Cleared 510(K)
- K010690SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR2Cleared 510(K)
- K010527SYNTHES (USA) IMF SCREWS2Cleared 510(K)
- K002935SYNTHES 1.5MM TI BROW LIFT SCREW2Cleared 510(K)
- K002423LACTOSORB PUSH SCREW2Cleared 510(K)
- K993493THE AUTOTAC SYSTEM2Cleared 510(K)
- K993575RESOLVE QUICKANCHOR2Cleared 510(K)
- K980760KLS-MARTIN MMF SCREW2Cleared 510(K)
- K993327TALON ANCHOR SNAP-PAK2Cleared 510(K)
- K992623MITEK MINI ANCHOR2Cleared 510(K)
- K982951IMTEC BIOPIN2Cleared 510(K)
- K983728LORENZ IMF SCREW2Cleared 510(K)
- K983485SYNTHES 1.3 MM SELF-DRILLING SCREW2Cleared 510(K)
- K981881DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING2Cleared 510(K)
- K9816662.5 MM LACTOSORB SCREWS2Cleared 510(K)
- K982927QUICK TAP SELF DRILLING SCREW2Cleared 510(K)
- K981459MEMBRANE TACK2Cleared 510(K)
- K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR2Cleared 510(K)
- K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS2Cleared 510(K)
- K974817DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM2Cleared 510(K)
- K974392LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM2Cleared 510(K)
- K9724803I BIORESORBABLE FIXATION TACK2Cleared 510(K)
- K973180IMTEC BONE TAC2Cleared 510(K)
- K973056BONE GRAFT SCREW SYSTEM2Cleared 510(K)
- K962774OSTEOMED QUICKFIX2Cleared 510(K)
- K963546SMF TITANIUM (TI) ALLOY BONE SCREWS2Cleared 510(K)
- K964261SMF STAINLESS STEEL BONE SCREWS2Cleared 510(K)
- K961418OSTEOMED MSS2Cleared 510(K)
- K960945IMZ MEMBRANE TACK SYSTEM2Cleared 510(K)
- K955369MEMFIX2Cleared 510(K)
- K9551402.0 X 6MM SCREW2Cleared 510(K)
- K952167IMZ BONE TACK SYSTEM2Cleared 510(K)
- K951510ACE BONE SCREW TACKING KIT2Cleared 510(K)
- K910427MEMFIX SCREWS2Cleared 510(K)
- K911936OSTEOMED SBF SYSTEM (SBF)2Cleared 510(K)
- K911165SCREW, BONE, MAXILLOFACIAL2Cleared 510(K)
- K770131LEW PROSTHETIC LOCKING DEVICE2Cleared 510(K)
- K761228LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM2Cleared 510(K)
- DZMNeedle, Dental1Product Code
- DZNInstruments, Dental Hand1Product Code
- DZPInstrument, Diamond, Dental1Product Code
- DYXLock, Wire, And Ligature, Intraoral2Product Code
- DZADrill, Dental, Intraoral1Product Code
- DZHSaw, Bone, Ac-Powered2Product Code
- DZIDrill, Bone, Powered2Product Code
- EAXMirror, Mouth1Product Code
- EAYLight, Fiber Optic, Dental1Product Code
- EAZLight, Operating, Dental1Product Code
- EBALight, Surgical Headlight1Product Code
- EBWController, Foot, Handpiece And Cord1Product Code
- ECBUnit, Syringe, Air And/Or Water1Product Code
- ECPInstrument, Ligature Tucking, Orthodontic1Product Code
- ECQAligner, Bracket, Orthodontic1Product Code
- ECRSetter, Band, Orthodontic1Product Code
- ECSPusher, Band, Orthodontic1Product Code
- ECTDriver, Band, Orthodontic1Product Code
- EFAHandpiece, Belt And/Or Gear Driven, Dental1Product Code
- EFBHandpiece, Air-Powered, Dental1Product Code
- EFKForceps, Articulation Paper1Product Code
- EFLForceps, Dressing, Dental1Product Code
- EGIParallelometer1Product Code
- EGMInjector, Jet, Mechanical-Powered2Product Code
- EGNScissors, Surgical Tissue, Dental1Product Code
- EGQInjector, Jet, Gas-Powered2Product Code
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental1Product Code
- EIBSyringe, Irrigating (Dental)1Product Code
- EICSyringe, Periodontic, Endodontic, Irrigating1Product Code
- EIDSyringe, Restorative And Impression Material1Product Code
- EIFAccessories, Retractor, Dental1Product Code
- EIGRetractor, All Types1Product Code
- EIKCarver, Wax, Dental1Product Code
- EILGauge, Depth, Instrument, Dental1Product Code
- EIRScissors, Collar And Crown1Product Code
- EISRemover, Crown1Product Code
- EIXProbe, Periodontic1Product Code
- EIYInstrument, Filling, Plastic, Dental1Product Code
- EJBHandle, Instrument, Dental1Product Code
- EJYPliers, Operative1Product Code
- EJZKnife, Margin Finishing, Operative1Product Code
- EKAFile, Margin Finishing, Operative1Product Code
- EKBExplorer, Operative1Product Code
- EKCExcavator, Dental, Operative1Product Code
- EKDInstrument, Cutting, Operative1Product Code
- EKECurette, Operative1Product Code
- EKFInstrument, Contouring, Matrix, Operative1Product Code
- EKGCondenser, Amalgam And Foil, Operative1Product Code
- EKHCarver, Dental Amalgam, Operative1Product Code
- EKICarrier, Amalgam, Operative1Product Code
- EKJBurnisher, Operative1Product Code
- EKKSpreader, Pulp Canal Filling Material, Endodontic1Product Code
- EKPReamer, Pulp Canal, Endodontic1Product Code
- EKQPreparer, Root Canal Endodontic1Product Code
- EKRPlugger, Root Canal, Endodontic1Product Code
- EKSFile, Pulp Canal, Endodontic1Product Code
- EKTCurette, Endodontic1Product Code
- EKWBroach, Endodontic1Product Code
- EKXHandpiece, Direct Drive, Ac-Powered1Product Code
- EKYHandpiece, Water-Powered1Product Code
- EKZUnit, Electrosurgical, And Accessories, Dental2Product Code
- ELAInstrument, Hand, Calculus Removal1Product Code
- ELBScaler, Rotary2Product Code
- ELCScaler, Ultrasonic2Product Code
- EMDHemostat, Surgical1Product Code
- EMEPunch, Biopsy, Surgical1Product Code
- EMGForceps, Tooth Extractor, Surgical1Product Code
- EMHForceps, Rongeur, Surgical1Product Code
- EMIFile, Bone, Surgical1Product Code
- EMJElevator, Surgical, Dental1Product Code
- EMKCurette, Surgical, Dental1Product Code
- EMLChisel, Bone, Surgical1Product Code
- EMMChisel, Osteotome, Surgical1Product Code
- EMNScaler, Periodontic1Product Code
- EMOKnife, Periodontic1Product Code
- EMPMarker, Periodontic1Product Code
- EMQHoe, Periodontic1Product Code
- EMRFile, Periodontic1Product Code
- EMSCurette, Periodontic1Product Code
- JEPRetainer, Matrix1Product Code
- JEXPlier, Orthodontic1Product Code
- JEYPlate, Bone2Product Code
- KMWHandpiece, Rotary Bone Cutting2Product Code
- MDLImplant, Transmandibular2Product Code
- MQNExternal Mandibular Fixator And/Or Distractor2Product Code
- MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation2Product Code
- NEIProsthesis, Condyle, Mandibular, Temporary2Product Code
- NLDInstrument, Diamond, Dental, Reprocessed1Product Code
- NMWNeedle, Dental, Reprocessed1Product Code
- NYCDental Prophylaxis Kit1Product Code
- NYFGingival Retraction Kit1Product Code
- NYGLapping Tool Kit1Product Code
- NYLHandpiece, Air-Powered, Root Canal Irrigation1Product Code
- PLVDental Stereotaxic Instrument2Product Code
- PWLOral Surgery Tray1Product Code
- NVKLaser, Dental, Soft Tissue2Product Code
- OAJCatheter, Drainage, Intraoral/Extraoral1Product Code
- PEMDental Barriers And Sleeves2Product Code
- QRYDental Navigation System2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- 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
Neo GBR System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160991
- 510(k) Type
- Traditional
- Applicant
- NEOBIOTECH CO., LTD.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/10/2017
- Days to Decision
- 277 days
- Submission Type
- Summary