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
- 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
- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)2Cleared 510(K)
- K240651MRI Universal2Cleared 510(K)
- K233874tmCMF Solution2Cleared 510(K)
- K232889METICULY Patient-specific titanium maxillofacial mesh implant2Cleared 510(K)
- K232350Stryker Facial iD System2Cleared 510(K)
- K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System2Cleared 510(K)
- K230733Stryker Resorbable Fixation System2Cleared 510(K)
- K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate2Cleared 510(K)
- K220360Tandry CMF Plate System2Cleared 510(K)
- K221855Universal CMF System2Cleared 510(K)
- K210731KLS Martin Individual Patient Solutions2Cleared 510(K)
- K213777Stryker Resorbable Fixation System2Cleared 510(K)
- K202969Biomet Microfixation OmniMax MMF System2Cleared 510(K)
- K202918OsteoSync™ Ti Dental Mesh2Cleared 510(K)
- K203282TECHFIT Patient-Specific Maxillofacial System2Cleared 510(K)
- K193280MedCAD® AccuPlate® Patient-Specific Plate2Cleared 510(K)
- K201944DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)2Cleared 510(K)
- K182759BoniPlus Dental G-Mesh System2Cleared 510(K)
- K192747Yxoss CBR®2Cleared 510(K)
- K191997FAICO CMF System2Cleared 510(K)
- K193143Stryker Facial iD Plating System2Cleared 510(K)
- K193136Stryker Customized Mandible Recon Plate Kit2Cleared 510(K)
- K192655Depuy Synthes Maxillofacial Portfolio - MR Conditional2Cleared 510(K)
- K182758MCI - CMF System2Cleared 510(K)
- K191028KLS Martin Individual Patient Solutions2Cleared 510(K)
- K190696Stryker Surgeon iD Mandible Recon Plate2Cleared 510(K)
- K182609Delphos Implants Rigid Fixation System2Cleared 510(K)
- K182305Stryker Facial iD Plating System2Cleared 510(K)
- K180204CranioMaxillofacial Fixation (CMF) System - CMF Visionare2Cleared 510(K)
- K180249OmniPore DUROMAX Surgical Implants2Cleared 510(K)
- K180962KLS Martin Individual Patient Solutions2Cleared 510(K)
- K173039TruMatch CMF Titanium 3D Printed Implant2Cleared 510(K)
- K170697GBR system2Cleared 510(K)
- K172354OssBuilder System2Cleared 510(K)
- K173320KLS Martin L1 MMF System2Cleared 510(K)
- K163579KLS Martin Individual Patient Solutions2Cleared 510(K)
- K170773Stryker Universal Mesh2Cleared 510(K)
- K172572Stryker Upper-Face AXS screws and Mid-Face AXS screws2Cleared 510(K)
- K170272TruMatch CMF Titanium 3D Printed Implant System2Cleared 510(K)
- K171364MP LeFort I Plates2Cleared 510(K)
- K160363OPTIMUS CMF SYSTEM2Cleared 510(K)
- K152326Biomet Microfixation OmniMax MMF System2Cleared 510(K)
- K150965LeForte System II2Cleared 510(K)
- K143730GBR System2Cleared 510(K)
- K142568Stryker MEDPOR TITAN 3D Orbital Floor Implant2Cleared 510(K)
- K143338Argulated Locking Plates2Cleared 510(K)
- K143336Biomet Microfixation OmniMax MMF System2Cleared 510(K)
- K140037OPTIMUS CMF SYSTEM2Cleared 510(K)
- K141764TRISTAR BONE GRAFT FIXATION SYSTEM2Cleared 510(K)
- K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM2Cleared 510(K)
- K141165MATRIXWAVE MMF SYSTEM2Cleared 510(K)
- K133461STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM2Cleared 510(K)
- K133304RXG DISTRACTION SYSTEM2Cleared 510(K)
- K121235LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM2Cleared 510(K)
- K132519STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT2Cleared 510(K)
- K132600FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING2Cleared 510(K)
- K131289I-GEN2Cleared 510(K)
- K130840SMARTBUILDER SYSTEM (SB1)2Cleared 510(K)
- K131674PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING2Cleared 510(K)
- K123786STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM2Cleared 510(K)
- K122647SYNTHES PATIENT SPECIFIC PLATE2Cleared 510(K)
- K122890INION CPS ORBITAL PLATES2Cleared 510(K)
- K113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K122313STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM2Cleared 510(K)
- K120951SMARTBUILDER SYSTEM2Cleared 510(K)
- K121589BIOMET MICROFIXATION FACIAL PLATING SYSTEM2Cleared 510(K)
- K121574SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K113512BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM2Cleared 510(K)
- K120271ARTISAN SPACE MAINTENANCE SYSTEM2Cleared 510(K)
- K112457LEFORTE SYSTEM BONE PLATE & SCREW2Cleared 510(K)
- K112064RESORB X-G2Cleared 510(K)
- K111761NEO TITANIUM MESH, CTI-MEM2Cleared 510(K)
- K113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES2Cleared 510(K)
- K110926BONE PLATE; BONE SCREW2Cleared 510(K)
- K110259ARCHITEX SPACE MAINTENANCE SYSTEM2Cleared 510(K)
- K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE2Cleared 510(K)
- K103778LEFORTE NEURO SYSTEM BONE PLATE2Cleared 510(K)
- K102656SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM2Cleared 510(K)
- K102641MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE2Cleared 510(K)
- K100779SUSTAIN SPACE MAINTENANCE SYSTEM2Cleared 510(K)
- K091807MEDPOR FIXATION SYSTEM2Cleared 510(K)
- K091812FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS2Cleared 510(K)
- K092743THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM2Cleared 510(K)
- K091233SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES2Cleared 510(K)
- K091679LEFORTE SYSTEM BONE PLATE2Cleared 510(K)
- K091144SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES2Cleared 510(K)
- K083388SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM2Cleared 510(K)
- K082335SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K073307MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K082757MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM2Cleared 510(K)
- K080862SONICWELD RX (RESORB-X)2Cleared 510(K)
- K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEM2Cleared 510(K)
- K081067FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)2Cleared 510(K)
- K080331SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM2Cleared 510(K)
- K072528ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES2Cleared 510(K)
- K072463SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM2Cleared 510(K)
- K071612MODUS TRILOCK 2.0/2.3/2.52Cleared 510(K)
- K062436SIS SINUS IMPLANT STABILIZER2Cleared 510(K)
- K070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES2Cleared 510(K)
- K063790THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM2Cleared 510(K)
- K061881OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM2Cleared 510(K)
- K062789SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES2Cleared 510(K)
- K061507SONICWELD RX ENDOBROW FIXATION2Cleared 510(K)
- K060177KLS MARTIN RIGID FIXATION - STERILE2Cleared 510(K)
- K060492AESCULAP CRANIOFACIAL PLATE AND SCREW2Cleared 510(K)
- K052444INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K051236RESORB-X SF2Cleared 510(K)
- K051845THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM2Cleared 510(K)
- K051293CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM2Cleared 510(K)
- K051341INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-10592Cleared 510(K)
- K050669JEIL BONE FIXATION SYSTEM2Cleared 510(K)
- K050608SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM2Cleared 510(K)
- K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K050204SYNTHES RAPID RESORBABLE TACK SYSTEM2Cleared 510(K)
- K043297MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM2Cleared 510(K)
- K042987MODIFICATION TO SYNTHES CRANIAL PLATES2Cleared 510(K)
- K042365SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM2Cleared 510(K)
- K042517BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS2Cleared 510(K)
- K040650BONAMATES SERIES2Cleared 510(K)
- K030425LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER2Cleared 510(K)
- K033092THE GNATHOMETER2Cleared 510(K)
- K030989OSTEOSORB TACK FIXATION SYSTEM2Cleared 510(K)
- K040272SYNTHES (USA) CRANIOFACIAL PLATES2Cleared 510(K)
- K032520ORTRAUTEK TRAUMA SYSTEM2Cleared 510(K)
- K033194INION CPS BABY 1.5 BIOABSORBABLE SYSTEM2Cleared 510(K)
- K031989ORTRAUTEK ORTHOGNATHIC SYSTEM2Cleared 510(K)
- K0331211.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES2Cleared 510(K)
- K033160SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES2Cleared 510(K)
- K031659UNIVERSAL NEURO SYSTEM2Cleared 510(K)
- K031761SYNTHES (USA) NEW/STERIAL ORBITAL PLATES2Cleared 510(K)
- K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWS2Cleared 510(K)
- K031028THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K030806BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K030069SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K022035OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB2Cleared 510(K)
- K022844SYNTHES RESORBABLE CONTOURABLE MESH2Cleared 510(K)
- K022185UNIVERSAL CMF SYSTEM2Cleared 510(K)
- K023810MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K023665MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K022012SYNTHES LOW PROFILE NEURO SYSTEM2Cleared 510(K)
- K023486OSSTAPLE, MAXILLOFACIAL2Cleared 510(K)
- K023488OSSTAPLE, CRANIOFACIAL2Cleared 510(K)
- K022890MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K021928SYNTHES (USA) RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K022005SYNTHES MIDFACE DISTRACTOR2Cleared 510(K)
- K021642SYNTHES CRANIOFACIAL PLATES2Cleared 510(K)
- K021618OSA RIGID INTERNAL FIXATION SYSTEM2Cleared 510(K)
- K021511CYTOFLEX MESH2Cleared 510(K)
- K021341NORMED BONE TRANSPORT DISTRACTION DEVICE2Cleared 510(K)
- K021342NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR2Cleared 510(K)
- K022033STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM2Cleared 510(K)
- K021684THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K021382SYNTHES (USA) AUTOMATED TACK DRIVER2Cleared 510(K)
- K020505SYNTHES TRANSLATING MAXILLARY DISTRACTOR2Cleared 510(K)
- K013672BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K011590RESORB-X RESORBABLE PLATING SYSTEM2Cleared 510(K)
- K014263NEWGEN/UNIVERSAL MANDIBULAR SYSTEM2Cleared 510(K)
- K011569BIOSORBFX O/M 2.0/2/4 SYSTEM2Cleared 510(K)
- K020087SYNTHES CRANIAL PLATES2Cleared 510(K)
- K013055THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K012910THE BIOPLATE MANDIBLE FIXATION SYSTEM2Cleared 510(K)
- K013039INION CPS 2.0 ORTHOGNATHIC PLATE2Cleared 510(K)
- K012413MACROPORE FX, PS, NS, LP2Cleared 510(K)
- K011698STRAUMANN GBR SYSTEM2Cleared 510(K)
- K010118NORMED MANDIBULAR FIXATION SYSTEM2Cleared 510(K)
- K003281LACTOSORB RAPIDFLAP2Cleared 510(K)
- K002207MACROPOREPX PEDIATRIC SYSTEM2Cleared 510(K)
- K011380MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K010499SYNTHES (USA) MIDFACE DISTRACTOR2Cleared 510(K)
- K010351INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K010687BIOSORBFX AND BIOSORBPDX MESH2Cleared 510(K)
- K010352CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K003786SMF RESORBABLE MESHES AND SHEETS2Cleared 510(K)
- K003549CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS2Cleared 510(K)
- K002083LORENZ RESORBABLE DISTRACTOR SYSTEM2Cleared 510(K)
- K003757THERMOFX MESH2Cleared 510(K)
- K002426THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K994060THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE2Cleared 510(K)
- K003883MOLINA ORBITAL MALAR DISTRACTOR2Cleared 510(K)
- K003393MAXILLARY DISTRACTOR2Cleared 510(K)
- K000560SYNTHES (USA) RESORBABLE TACK SYSTEM2Cleared 510(K)
- K003756BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES2Cleared 510(K)
- K003660LEIBINGER NEURO CLIP SYSTEM2Cleared 510(K)
- K000594LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE2Cleared 510(K)
- K002798CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS2Cleared 510(K)
- K002619NEWGEN SYSTEM2Cleared 510(K)
- K000696MACROPOREMX MANDIBULAR FIXATION SYSTEM2Cleared 510(K)
- K002879MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K992905CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K001530THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM2Cleared 510(K)
- K001219MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM2Cleared 510(K)
- K000836BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K001238LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM2Cleared 510(K)
- K994154MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES2Cleared 510(K)
- K993862MODUS SAGITTAL SPLIT PLATE2Cleared 510(K)
- K992683MODUS 2.5 MANDIBULAR TRAUMA SET2Cleared 510(K)
- K992682MODUS 2.5 MANDIBULAR RECONSTRUCTION SET2Cleared 510(K)
- K992330THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K992158LACTOSORB SHEETS2Cleared 510(K)
- K990920DRG TITANIUM BONE PLATE2Cleared 510(K)
- K990140NORMED BONE TRANSPORT2Cleared 510(K)
- K983360MACROPORE PROTECTIVE SHEET2Cleared 510(K)
- K982721BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM2Cleared 510(K)
- K984230OSTEO-MESH TM-3002Cleared 510(K)
- K983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES2Cleared 510(K)
- K983535THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-10102Cleared 510(K)
- K983528MICRO DYNAMIC MESH2Cleared 510(K)
- K981526ACE ALVEOLAR DISTRACTOR2Cleared 510(K)
- K982139BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES2Cleared 510(K)
- K980983THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K980927LACTOSORB PANELS AND FASTENERS2Cleared 510(K)
- K98107020-HOLE ADAPTATION PLATE2Cleared 510(K)
- K980512LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW2Cleared 510(K)
- K973924FRIOS BONESHIELD2Cleared 510(K)
- K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)2Cleared 510(K)
- K974554SYNTHES RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K973484CHIN DISTRACTOR2Cleared 510(K)
- K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM2Cleared 510(K)
- K972463THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY2Cleared 510(K)
- K972322LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES2Cleared 510(K)
- K972154COHEN DISTRACTOR2Cleared 510(K)
- K972166GUERRERO - BELL DISTRACTOR2Cleared 510(K)
- K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR2Cleared 510(K)
- K970841IMTEC/TITANIUM MESH2Cleared 510(K)
- K970911LEE PLATE2Cleared 510(K)
- K970256INTRAORAL MANDIBULAR DISTRACTION DEVICE2Cleared 510(K)
- K964649VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE2Cleared 510(K)
- K964328SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE2Cleared 510(K)
- K963394OSTEOMED TRAM2Cleared 510(K)
- K963740LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS2Cleared 510(K)
- K961976THE BIOPLATE FIXATION SYSTEM2Cleared 510(K)
- K961421SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM2Cleared 510(K)
- K960514TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)2Cleared 510(K)
- K9609143I OSSEOUS FIXATION SYSTEM(S)2Cleared 510(K)
- K954385SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM2Cleared 510(K)
- K953806SYNTHES (USA) MIDFACIAL SYSTEM2Cleared 510(K)
- K953273BIOPLATE RIGID FIXATION BONE PLATING SYSTEM2Cleared 510(K)
- K953385LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM2Cleared 510(K)
- K945500WELLS JOHNSON FIXATION SYSTEM2Cleared 510(K)
- K9533869I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS2Cleared 510(K)
- K9528123I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS2Cleared 510(K)
- K9528113I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS2Cleared 510(K)
- K951687MESH TITANIUM IMPLANT SYSTEM2Cleared 510(K)
- K951689TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM2Cleared 510(K)
- K951691CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM2Cleared 510(K)
- K951690TITANIUM MINIPLATE SYSTEM2Cleared 510(K)
- K951688MICRO TITANIUM PLATE SYSTEM2Cleared 510(K)
- K950595LUHR MANDIBULAR/SMALL FIXATION IMPLANTS2Cleared 510(K)
- K952168TITANIUM MANDIBULAR FRACTURE SYSTEM2Cleared 510(K)
- K951392MINIBONEPLATE SYSTEM2Cleared 510(K)
- K950045KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM2Cleared 510(K)
- K943071THE TITANIUM FIXATION SYSTEM2Cleared 510(K)
- K944565KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)2Cleared 510(K)
- K944560MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST2Cleared 510(K)
- K944561MICRO OSTEOSYNTHESIS SYSTEM (1.0)2Cleared 510(K)
- K943348KLS CHIN PLATE SYSTEM2Cleared 510(K)
- K943346MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K943347KLS MINI OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K943345MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM2Cleared 510(K)
- K931539NORMED TITANIUM MINIPLATE SYSTEM2Cleared 510(K)
- K923705AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS2Cleared 510(K)
- K932492IMPLANTOLOGY MODULE, MODEL 21752Cleared 510(K)
- K923419TISMESH SYSTEM2Cleared 510(K)
- K924138OSTEOMED M3 SYSTEM (SBF SYSTEM)2Cleared 510(K)
- K922741LORENZ 1.0 MM SYSTEM2Cleared 510(K)
- K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREW2Cleared 510(K)
- K921801MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM2Cleared 510(K)
- K913688BUD MAXILLOFACIAL IMPLANT SYSTEM2Cleared 510(K)
- K910038LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM2Cleared 510(K)
- K901940LUHR MICRO MESH2Cleared 510(K)
- K901941LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES2Cleared 510(K)
- K901095BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY2Cleared 510(K)
- K901094HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY2Cleared 510(K)
- K896404TITAMED ANTWERP SYSTEM2Cleared 510(K)
- K884523MARTIN-CHAMPY TITAN SET2Cleared 510(K)
- K873926STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT2Cleared 510(K)
- K870041FLEXIBLE FASCICULATED BONE PLATE2Cleared 510(K)
- K862532DUMBACH TITANIUM MESH IMPLANT SYSTEM2Cleared 510(K)
- K862534PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS2Cleared 510(K)
- K862505MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM2Cleared 510(K)
- K862533MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE2Cleared 510(K)
- K862482STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS2Cleared 510(K)
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- K855224ACROMED NESTED BONE PLATE2Cleared 510(K)
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- 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
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- OphthalmicReview Panel
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SMARTBUILDER SYSTEM (SB1)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K130840
- 510(k) Type
- Traditional
- Applicant
- OSSTEM IMPLANT CO.,LTD
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/18/2013
- Days to Decision
- 175 days
- Submission Type
- Summary