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
- 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
- K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement System2Cleared 510(K)
- K241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement2Cleared 510(K)
- K232842Balloon Inflation System2Cleared 510(K)
- K240084V-STRUT® Vertebral Implant2Cleared 510(K)
- K231340Renova Spine Balloon Catheter2Cleared 510(K)
- K221697INJECTION PIN (KIP(02031-02061) (03031-03061))2Cleared 510(K)
- K223294SpineJack® Expansion Kit2Cleared 510(K)
- K220131KYPHON VuE Bone Cement2Cleared 510(K)
- K211797TRACKER Plus Kyphoplasty System2Cleared 510(K)
- K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement2Cleared 510(K)
- K202393SpineJack Expansion Kit2Cleared 510(K)
- K201831CONFIDENCE Spinal Cement System2Cleared 510(K)
- K192449Joline Kyphoplasty System Allevo2Cleared 510(K)
- K191709V-STRUT Vertebral Implant2Cleared 510(K)
- K192335TRACKER Kyphoplasty System2Cleared 510(K)
- K192403VK100 Percutaneous Vertebral Augmentation System2Cleared 510(K)
- K181262SpineJack Expansion Kit2Cleared 510(K)
- K172871SpineKure Kyphoplasty System2Cleared 510(K)
- K180700KYPHON HV-R Bone Cement2Cleared 510(K)
- K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters2Cleared 510(K)
- K161114HIGH V+2Cleared 510(K)
- K163032Kyphon Xpede Bone Cement2Cleared 510(K)
- K162283DCM Kyphoplasty System2Cleared 510(K)
- K162618CONCORD Plus Radiopaque Bone Cement2Cleared 510(K)
- K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)2Cleared 510(K)
- K160983Kyphon HV-R Bone Cement2Cleared 510(K)
- K153296MEDINAUT Kyphoplasty System2Cleared 510(K)
- K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters2Cleared 510(K)
- K151227KYPHON XPEDE Bone Cement2Cleared 510(K)
- K150582Vertaplex® High Viscosity (HV) Radiopaque Bone Cement2Cleared 510(K)
- K150460KYPHON (R) HV-R(R) Bone Cement2Cleared 510(K)
- K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml2Cleared 510(K)
- K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)2Cleared 510(K)
- K143006GUARDIAN-SG Inflatable Bone Expander System2Cleared 510(K)
- K141419ZVPLASTY2Cleared 510(K)
- K141930OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML2Cleared 510(K)
- K141141KIVA VCF TREATMENT SYSTEM2Cleared 510(K)
- K140937OSSEOFLEX SB2Cleared 510(K)
- K132620INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL2Cleared 510(K)
- K133669MEDINAUT KYPHOPLASTY SYSTEM2Cleared 510(K)
- K132817KIVA VCF TREATMENT SYSTEM2Cleared 510(K)
- K133372CROSSTREES PVA POD2Cleared 510(K)
- K130089CROSSTREES PVA POD2Cleared 510(K)
- K122503PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON2Cleared 510(K)
- K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM2Cleared 510(K)
- K123942STRYKER IVAS BALLOON CATHETER2Cleared 510(K)
- K130402SPIDER SYSTEM KOLIBRI CEMENT NEEDLE2Cleared 510(K)
- K122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEM2Cleared 510(K)
- K100404ASCENDX VCF REDUCTION SYSTEM2Cleared 510(K)
- K122533OSSEOFLEX SB INFLATABLE BONE TAMP2Cleared 510(K)
- K121876VERTECEM II CEMENT KIT2Cleared 510(K)
- K113742KMC KYPHOPLASTY SYSTEM2Cleared 510(K)
- K113452ACU-CUT VERTEBRAL AUGMENTATION SYSTEM2Cleared 510(K)
- K113154IVAS BALLOON CATHETER2Cleared 510(K)
- K113477IVAS 20MM (10 GAUGE) BALLOON CATHETER2Cleared 510(K)
- K112907CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G2Cleared 510(K)
- K110604VBB SYSTEM2Cleared 510(K)
- K093477SHIELD KYPHOPLASTY SYSTEM2Cleared 510(K)
- K111593GUARDIAN INFLATABLE BONE EXPANDER SYSTEM2Cleared 510(K)
- K110998AFFIRM (TM) VCF SYSTEM2Cleared 510(K)
- K103807IVAS 2-10MM (10 GUAGE) BALLON CATHETER2Cleared 510(K)
- K102397KYPHON XPEDE BONE CEMENT2Cleared 510(K)
- K110183ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE2Cleared 510(K)
- K103816COHESION BONE CEMENT2Cleared 510(K)
- K103064AVAMAX VERTEBRAL BALLOON2Cleared 510(K)
- K103433F202Cleared 510(K)
- K100479PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE2Cleared 510(K)
- K093828KYPH X HV-R BONE CEMENT2Cleared 510(K)
- K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS2Cleared 510(K)
- K093463AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS10202Cleared 510(K)
- K091234SKELTEX ISV2Cleared 510(K)
- K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)2Cleared 510(K)
- K090435VERTECEM2Cleared 510(K)
- K091606VERTAPLEX HV (SINGLE PACK AND DUAL PACK)2Cleared 510(K)
- K090211INFLATABLE BONE TAMP2Cleared 510(K)
- K080108CORTOSS BONE AUGMENTATION MATERIAL2Cleared 510(K)
- K090460BONOS INJECT2Cleared 510(K)
- K080873OPACITY + BONE CEMENT2Cleared 510(K)
- K071375MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)2Cleared 510(K)
- K072118STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT2Cleared 510(K)
- K071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT2Cleared 510(K)
- K072133AVAFLEX VERTEBRAL AUGMENTATION NEEDLE2Cleared 510(K)
- K072496MODIFICATION TO SPACE CPSXL BONE CEMENT2Cleared 510(K)
- K070351SPACE 360 DELIVERY SYSTEM2Cleared 510(K)
- K070527ARCUATE VERTEBRAL AUGMENTATION SYSTEM2Cleared 510(K)
- K063248ARCUATE VERTEBRAL AUGMENTATION SYSTEM2Cleared 510(K)
- K063438VSPSPN2Cleared 510(K)
- K063067CONFIDENCE FENESTRATED INTRODUCER NEEDLE2Cleared 510(K)
- K062452KIT MENDEC SPINE AND DELIVERY SYSTEM2Cleared 510(K)
- K062424CONFIDENCE EX HIGH VISCOSITY BONE CEMENT2Cleared 510(K)
- K061531SPACE CPSXL BONE CEMENT2Cleared 510(K)
- K060425PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA2Cleared 510(K)
- K053336STAXX FX SYSTEM2Cleared 510(K)
- K060300CONFIDENCE HIGH VISCOSITY BONE CEMENT2Cleared 510(K)
- K043593SPINE-FIX BIOMIMETIC BONE CEMENT2Cleared 510(K)
- K060148EBI VERTEBROPLASTY SYSTEMS2Cleared 510(K)
- K053180PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS2Cleared 510(K)
- K042691VERTEFIX VERTEBROPLASTY PROCEDURE SET2Cleared 510(K)
- K043406VERTEBROPLASTIC RADIOPAQUE BONE CEMENT2Cleared 510(K)
- K050864PARALLAX ACRYLIC RESIN WITH TRACERS TA2Cleared 510(K)
- K042415MENDEC SPINE2Cleared 510(K)
- K043518RADIOPAQUE BONE CEMENT2Cleared 510(K)
- K042168CONCORD Radiopaque Bone Cement2Cleared 510(K)
- K042947PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-0032Cleared 510(K)
- K041584KYPHX HV-R BONE CEMENT, MODEL C01A2Cleared 510(K)
- K033801KYPHX HV-R, MODEL C01A2Cleared 510(K)
- 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
GUARDIAN-SG Inflatable Bone Expander System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K143006
- 510(k) Type
- Traditional
- Applicant
- BM KOREA CO., LTD.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/16/2015
- Days to Decision
- 88 days
- Submission Type
- Summary