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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)2Cleared 510(K)
- K231526CORAIL Cemented Femoral Stem2Cleared 510(K)
- K223441SpaceFlex Acetabular Cup2Cleared 510(K)
- K221794Vario-Cup System2Cleared 510(K)
- K220492COPAL exchange G hip spacer2Cleared 510(K)
- K200709Kyocera Bipolar Hip System2Cleared 510(K)
- K192236Fitmore Hip Stem2Cleared 510(K)
- K191016COPAL exchange G Hip and Knee Spacers2Cleared 510(K)
- K191297iNSitu Bipolar Hip System2Cleared 510(K)
- K191569Implantcast ic-Bipolar Head System2Cleared 510(K)
- K183114Corin BiPolar-i2Cleared 510(K)
- K173455SurgTech Bipolar Head System2Cleared 510(K)
- K180130ELEOS™ Bipolar Acetabular System2Cleared 510(K)
- K16308140-42mm BiPolar Head and 22mm Femoral Head2Cleared 510(K)
- K170072Fitmore® Hip Stem2Cleared 510(K)
- K152439U2 Bipolar Implant and 22mm Femoral Head2Cleared 510(K)
- K143113Klassic BiPolar System2Cleared 510(K)
- K132539RING-LOK MODULAR BIPOLAR SYSTEM2Cleared 510(K)
- K131354RENOVIS BIPOLAR HIP SYSTEM2Cleared 510(K)
- K123991DEPUY CORAIL AMT HIP PROSTHESIS2Cleared 510(K)
- K121509TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT2Cleared 510(K)
- K112019BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP2Cleared 510(K)
- K100761BIOPRO POLAR HEAD2Cleared 510(K)
- K101670UNITED U2 BIPOLAR IMPLANT2Cleared 510(K)
- K100151APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)2Cleared 510(K)
- K091967MEDACTA BIPOLAR HEAD2Cleared 510(K)
- K082468APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)2Cleared 510(K)
- K082705BIOPRO BIPOLAR HEAD, MODELS 18130-181522Cleared 510(K)
- K080979STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT2Cleared 510(K)
- K080647ACCIN BIPOLAR HEAD SYSTEM2Cleared 510(K)
- K062693GLADIATOR BIPOLAR SYSTEM2Cleared 510(K)
- K060707AESCULAP BIPOLAR ACETABULAR CUP2Cleared 510(K)
- K052990STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM2Cleared 510(K)
- K050269U1 HIP SYSTEM - BIPOLAR2Cleared 510(K)
- K050966PIVOT BIPOLAR FEMORAL HEAD2Cleared 510(K)
- K040947DURASUL BIPOLAR2Cleared 510(K)
- K023743SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM2Cleared 510(K)
- K014072FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)2Cleared 510(K)
- K013211MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS2Cleared 510(K)
- K010081ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS2Cleared 510(K)
- K003363M2A 32MM TAPER SYSTEM2Cleared 510(K)
- K991990TRI-POLAR SYSTEM2Cleared 510(K)
- K982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)2Cleared 510(K)
- K982447PLUS BIPOLAR PROSTHESIS COCRMO2Cleared 510(K)
- K982389ODC B2 BIPOLAR CUP2Cleared 510(K)
- K981238BIPOLAR FEMORAL HEAD2Cleared 510(K)
- K980801J-FX BIPOLAR HEAD2Cleared 510(K)
- K970447IMPLEX BIPOLAR HIP SYSTEM2Cleared 510(K)
- K970284ARTOS, DIPLOS SYSTEM2Cleared 510(K)
- K960643ADVANTAGE MAPF HIP FEMORAL COMPONENT2Cleared 510(K)
- K963885ULTIMA FX FEMORAL HIP STEMS2Cleared 510(K)
- K962448PRIMALOC CEMENTED HIP SYSTEM2Cleared 510(K)
- K961793BI-LOC BIPOLAR CUP2Cleared 510(K)
- K945518P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT2Cleared 510(K)
- K953977PRIMALOC CEMENTLESS HIP SYSTEM2Cleared 510(K)
- K940743UHMWPE COMPONENTS-CHANGE IN PACKAGING2Cleared 510(K)
- K953510HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS2Cleared 510(K)
- K945793P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR2Cleared 510(K)
- K941534MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM2Cleared 510(K)
- K944132P.F.C. TOTAL HIP SYSTEM2Cleared 510(K)
- K934159IOI COCR UNIPOLAR PROSTHESIS2Cleared 510(K)
- K931655P.F.C. BIPOLAR HIP SYSTEM2Cleared 510(K)
- K925153IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM2Cleared 510(K)
- K926387TECHMEDICA STANDARD CEMENTED HIP SYSTEM2Cleared 510(K)
- K925536HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K925420TECHMEDICA STANDARD BIPOLAR SYSTEM2Cleared 510(K)
- K925897CORIN BIPOLAR PROSTHESIS2Cleared 510(K)
- K922560CONSENSUS(TM) BIPOLAR SYSTEM2Cleared 510(K)
- K913632BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM2Cleared 510(K)
- K905370EXACTECH BIPOLAR HIP PROSTHESIS2Cleared 510(K)
- K904383ACUFIT TOTAL HIP2Cleared 510(K)
- K900051MOORE TYPE ENDO PROSTHESIS2Cleared 510(K)
- K896257LEINBACH HIP PROSTHESIS2Cleared 510(K)
- K895120BATEMAN UPF II HIP PROSTHESIS SYSTEM2Cleared 510(K)
- K896266VS22 HIP PROSTHESIS2Cleared 510(K)
- K893872P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT2Cleared 510(K)
- K893959P.S.A. FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K884658ZIMMER BEADED THREADED ACETABULAR CUP2Cleared 510(K)
- K881289CORIN BIPOLAR PROSTHESIS2Cleared 510(K)
- K873815IOI BIPOLAR PROSTHESIS2Cleared 510(K)
- K873514JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS2Cleared 510(K)
- K872019BI-ARTICULAR II HIP DEVICE2Cleared 510(K)
- K862460FEMORAL HEMI-HIP PROSTHESIS2Cleared 510(K)
- K862057KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD2Cleared 510(K)
- K861566SLR BIPOLAR HIP ENDOPROSTHESIS2Cleared 510(K)
- K861105HOWMEDICA BIPOLAR PROSTHESIS2Cleared 510(K)
- K855231HOWMEDICA BIPOLAR PROSTHESIS2Cleared 510(K)
- K853795KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD2Cleared 510(K)
- K842344HASTINGS BIPOLAR ENDOPROSTHESIS2Cleared 510(K)
- K833404BDH BIPOLAR FEMORAL COMPONENT A32Cleared 510(K)
- K833991BIPOLAR HIP DEVICE2Cleared 510(K)
- K833175BIOMET BIPOLAR PROSTHESIS2Cleared 510(K)
- K823726SPECTRON CONVERSION ENDOPROSTHESIS CUP2Cleared 510(K)
- K823482101 UNIVERSAL ENDOPROSTHESIS2Cleared 510(K)
- K812672SELF-CENTERING HIP2Cleared 510(K)
- K810062BI-CENTRIC BI-POLAR ENDOPROSTHESIS2Cleared 510(K)
- K7918233M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM2Cleared 510(K)
- K781735ENDOPROSTHESIS SYSTEM, VARIO-HEAD2Cleared 510(K)
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ELEOS™ Bipolar Acetabular System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180130
- 510(k) Type
- Traditional
- Applicant
- Onkos Surgical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/23/2018
- Days to Decision
- 37 days
- Submission Type
- Summary